FDA and lifepack 15

Scout

Para-Noid
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Can anyone say woops?


http://www.dotmed.com/news/story/12444/


The U.S. Food and Drug Administration issued its most serious product recall on Physio-Control's LIFEPAK defibrillators Thursday, warning that the life-saving machines could shut down or turn on by themselves.

Once it turns on or off, the machines could then stay that way, the FDA said in a statement announcing the Class 1 recall.

Medtronic subsidiary Physio-Control blames the problem on a manufacturing defect involving an internal component that could cause an electrical short.

The recall applies to the LIFEPAK 15 monitors/defibrillators manufactured and distributed between March 26, 2009 and December 15, 2009.

The LIFEPAK defibrillators deliver jolts into the heart to revive patients stricken with sudden cardiac arrest. While the shorting could cause the device to fail, LIFEPAK says there are no known adverse incidents related to the recall.

The news comes only months after the FDA cleared the company to resume full domestic sales of its LIFEPAK defibrillators after nearly three years of a voluntary moratorium. In January 2007, the FDA docked the business for what it said were failures to properly investigate possible product defects. Physio-Control re-started full sales in February, after the company agreed to implement tougher quality control measures - measures the company now credits with helping catch the problem before anyone got hurt.

"This is an example of our quality system working the way it was designed to," said Physio-Control president Brian Webster in a statement. "We were able to detect this potential issue early, it was investigated, a solution was found and is being implemented. Our goal is to minimize issues in the field and maximize patient safety and customer satisfaction."

The company says it notified its customers about the problem March 4, 2010, and has begun servicing devices at no cost at most customer locations.

Headquartered in Redmond, Wash., the 55-year-old company is one of the pioneers of defibrillator technology.

Minneapolis, Minn.-based parent company Medtronic's stocks took a small tumble Thursday, closing at $44.15, down 1.16 percent.
 

WolfmanHarris

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And my service has just started purchasing on the LP15's to replace all our 12's. I think we've only got one or two at the moment for our Performance and Development Division to play with.

I was actually hoping for the Phillips monitor myself.
 

46Young

Level 25 EMS Wizard
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I'm quite happy with our Phillips monitors. My service replaced all of our LP 12's with the Phillips during the same time period that the recalled LP 15's were being issued.

It was explained to me that Physio was charging an absurd amount for the 15's when compared to Phillips. I don't remember exactly, but I think it was 18 grand a pop or so. I remember thinking what balls this company has charging so much for the new models.
 

WolfmanHarris

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Apparently the 15's are actually going to have decent battery life too. Lord knows the 12's are frigging awful for that.
 

46Young

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The Phiilip's battery is supposed to last 14 continuous hours. The monitor has two. That's 28 continuous hours give or take. No one runs their monitor 24/7. That means that you could get two or three days to a week without needing to change the batteries, assuming that you don't plug it in between calls.

How long does the LP 15 last in comparison?
 

WolfmanHarris

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How long does the LP 15 last in comparison?

Couldn't tell ya without looking up the specs on Medtronics site.

All we've been told so far was that we're getting them (along with replacements for all our bags) as part of our equipment replacement cycle this year. I can only hope it's as good as the Phillips.

Specs for a brand-new battery state 360 mins for monitoring = 6 hours. (Initially stated 12, reread the fine print and those numbers were for two batteries)
For defib, 420x 360j discharges.

There's lots of different Nicd models for the LP12 and I'm not sure which we're using at the moment (not at work) but the range for monitoring is from 110-120mins.
 
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Shishkabob

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Apparently the 15's are actually going to have decent battery life too. Lord knows the 12's are frigging awful for that.

I HATED the battery life on LP12s during my internship. I'd have to change out batteries after every call that I used the monitor on, and kept 2 extra batteries in the truck beyond the normal one they required.

I loved using the Phillips in school.
 

zmedic

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I'm surprised they didn't move the on/off switch on the 15. There have been a number of reports of users who go to shock or charge on the 12 and hitting the off button and turning them off. Not what you want during a cardiac arrest.
 

colafdp

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I'm surprised they didn't move the on/off switch on the 15. There have been a number of reports of users who go to shock or charge on the 12 and hitting the off button and turning them off. Not what you want during a cardiac arrest.

You do have to press and hold the power button on the 15 to turn it off. However, maybe if people are doing this, they should take a second and actually look at which button they're hitting.
 

Shishkabob

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I'm surprised they didn't move the on/off switch on the 15. There have been a number of reports of users who go to shock or charge on the 12 and hitting the off button and turning them off. Not what you want during a cardiac arrest.


You should really be looking at the monitor when you shock someone anyhow...
 

zmedic

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Adverse Design of Defibrillators: Turning Off the Machine When Trying to Shock
Annals of Emergency Medicine, Volume 52, Issue 5, Pages 512-514
C. Høyer, E. Christensen, B. Eika

", we observed that in 5 of 192 defibrillation attempts by the physicians, the monitor-defibrillator was inadvertently powered off. "

Hey, I've never turned one off during a code, but if the design makes it more likely it's a problem. Arguing that "people should look" doesn't really fix the problem. Moving the button to the other side of the machine does. Safety engineering is the reason why anesthesia is hundreds of times safer than it was 30 years ago. They decided to make the machines smart enough that it won't let you do dumb things like turn up the anesthesia gas so high that the patient doesn't get enough 02. etc etc.
 

BLSBoy

makes good girls go bad
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No sh*t it turns itself off and on.....its designed to do it at 0300 to do its self check...:rolleyes:
 

Shishkabob

Forum Chief
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Adverse Design of Defibrillators: Turning Off the Machine When Trying to Shock
Annals of Emergency Medicine, Volume 52, Issue 5, Pages 512-514
C. Høyer, E. Christensen, B. Eika

", we observed that in 5 of 192 defibrillation attempts by the physicians, the monitor-defibrillator was inadvertently powered off. "

Hey, I've never turned one off during a code, but if the design makes it more likely it's a problem. Arguing that "people should look" doesn't really fix the problem. Moving the button to the other side of the machine does. Safety engineering is the reason why anesthesia is hundreds of times safer than it was 30 years ago. They decided to make the machines smart enough that it won't let you do dumb things like turn up the anesthesia gas so high that the patient doesn't get enough 02. etc etc.


If they aren't taking the extra half second to look at the monitor and confirm what they are doing, then the problem lies on them.
 

WolfmanHarris

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If they aren't taking the extra half second to look at the monitor and confirm what they are doing, then the problem lies on them.

While the provider has ultimate responsibility, pt. safety and the prevention of medical errors is too important to take that tack. With everything going on during a call would it not make more sense to identify and mitigate areas where mistakes are likely. Wouldn't you rather have one less thing to worry about?

I'm also in favour of checklists for high risk, low instance procedures (i.e. RSI's, cric's). Lessons to be learned from the airline industry abound. I believe that not only have checklists found their way into various hospital units, but that forms of Crew Resource Management (CRM) are also being used in surgery in some areas.
 

Markhk

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If they aren't taking the extra half second to look at the monitor and confirm what they are doing, then the problem lies on them.

It's a human factors design issue. Infrequently used skill (the people in the study were Junior Internal Med Physicians in Europe getting ready to work on the ambulance) coupled with a system that wasn't designed with the idea that "to err is human".

Several AED brands try to address this by requiring the user push and hold the on/off button for several seconds if the user really wants to turn it off. I do recall one brand that states, "warning power button pushed" or something like that when the AED is recommending a shock.

This kind of reminds me how no one can find the Heartstart MRx "SYNC" button.
 

zmedic

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Linuss; said:
If they aren't taking the extra half second to look at the monitor and confirm what they are doing, then the problem lies on them.

By that logic pilots should just look at their instruments so they don't run out of gas, nurses should just not give the wrong meds, surgeons should know what foot they are operating on. And you can yell at people till you are blue in the face but those were all system problems that were vastly improved by doing things like having alarms sound when low on gas, changing drug packaging to deal with look alike/sound alike meds, having patients sign their operative site etc. etc.

I'd rather have it work right because it was well designed than worry that a rookie is going to kill my patient. Much better than have the satisfaction that "oh, I wouldn't have done what they did."
 

colafdp

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By that logic pilots should just look at their instruments so they don't run out of gas, nurses should just not give the wrong meds, surgeons should know what foot they are operating on. And you can yell at people till you are blue in the face but those were all system problems that were vastly improved by doing things like having alarms sound when low on gas, changing drug packaging to deal with look alike/sound alike meds, having patients sign their operative site etc. etc.

I'd rather have it work right because it was well designed than worry that a rookie is going to kill my patient. Much better than have the satisfaction that "oh, I wouldn't have done what they did."

maybe it should have that annoying security feature that comes with Windows. A popup saying "are you sure you want to do this?" lol
 

ceej

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LP12 battery life is atrocious. Nothing like changing your batteries in the middle of a code.

I have had nothing but positive experiences with the LP15, though. Worked three codes back to back to back with defib and went on to finish the shift on the same batteries.

The bluetooth integration is pretty neat and convenient, too. Nothing like typing my run report and having the code summary already attached.
 

lightsandsirens5

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You do have to press and hold the power button on the 15 to turn it off. However, maybe if people are doing this, they should take a second and actually look at which button they're hitting.

I don't know about the LPs, but on the Zolls it is the big round flashing orange button. Kind of hard to miss. Then again, it is tough to confuse a shock button with an "on-off" dial. I suppose the LP has an "on-off" button as opposed to a switch.

I would think though that it would be standard to have the shock button be different, bigger, flashing orange or red, etc.
 

ceej

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The LP 12 and 15 Shock button is red and the same size as the Charge and On/Off button.

Thinking back to the Lifepak 11, the defib side of that machine had two shock buttons which were small and round and required you to hold them both down simultaneously to discharge. Granted that was some time ago and that machine is lovingly referred to as the "Shockasaurus" now.
 
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