Defribrillators found to have flaws

greenspun.com : LUSENET : Grassroots Information Coordination Center (GICC) : One Thread

Before the rollover there was great concern over medical devices. This may be one of those concerns but will put in non-y2k.

Life Saving Defibrillators Found To Have Flaws Medtronic Implant Devices Could Malfunction

FRIDLEY, Minn., Posted 12:13 p.m. CST February 12, 2000 -- Medtronic Inc. has started notifying doctors of a flaw that might cause 50 of its implanted Gem II DR and Gem II VR defibrillators to malfunction.

The 50 were among a lot of about 1,100 defibrillators released last May in the United States, spokeswoman Jessica Stoltenberg said.

The implanted devices help hearts that beat too rapidly, shocking them back into rhythm.

Stoltenberg said that the company knows of no injuries resulting from the flaw -- a fracture in a component of the device. The flaw was corrected in subsequent lots of the defibrillators.

As a precaution, the company plans to notify doctors associated with the entire lot of 1,100 defibrillators of the problem by Monday. Doctors are advised to activate the Patient Alert System in the device, a feature that alerts patients of any problem with the unit.

Doctors will determine whether any of the devices should be replaced.

http://www.wcco.com/news/stories/news-20000212-181318.html

-- Martin Thompson (mthom1927@aol.com), February 12, 2000

Answers

I find this extremely alarming.

Questions:

1. Why were only 50 out of the whole lot affected? How do they know which ones they are?

2. Why, if these devices were distributed in May 99, are they ONLY NOW being recalled? Possibly because they began to malfunction AFTER the rollover? (Oh I know, the story says these things malfunctioned because of a "crack" and cracks know no dates. Interesting timing these "cracks" have.)

3. Why will a doctor (who is presumably not familiar with the technical working aspects of the machines, as most of physicians are not engineers) decide whether or not the defibrilators will be replaced? If the thing doesn't work, it doesn't work!

Most hospitals and other health care providers will not admit that in their Y2K prep work, they did not check EVERY defibrilator they had. They simply performed random checks. The largest health care network in my state had 2 defibrilatiors fail on Jan 1. That doesn't sound too serious, unless of course, you were the poor soul actually *attached* to the thing. As far as I know, both persons lived to tell the story.

It's all about playing the odds, IMHO.

-- Jen Bunker (jen@bunkergroup.com), February 12, 2000.


Moderation questions? read the FAQ