Hundreds of automated external defibrillators in Canada have failed when someone was trying to use the devices. And the malfunctions have led to at least 9 deaths, CBC News is reporting.
The news service made its determination after evaluating Health Canada documents tracking failure reports--562 over the past 5 years involving a patient. And many of the devices--102, in fact--either could not be turned on, or simply turned off without warning, according to the story.
So is this an indictment of Medtronic ($MDT), Zoll ($ZOLL), Philips ($PHG) and other companies that make AEDs? Not really. The issue comes down to maintenance. The devices often are neglected when it comes time to replace damaged or external parts like batteries or electrode pads, which generally need updating every few years, CBC reports. The devices may very well be fine at point of purchase, but they are being virtually abandoned until someone suddenly needs to use one.
External automatic defibrillators are designed for a non-expert to use in emergency situations, placed for easy access in public spaces such as malls. Canadian regulators license the devices for approval, and they told the news agency that AEDs remain beneficial despite equipment failure risks.
Still, Canadian resident Tanya Lahey, whose son needed a defibrillator that ended up having a dead battery, is pushing for some sort of national tracking system that would verify how often the portable devices are checked, according to the story.
In the U.S., the machines are 510(k) cleared, but there has been some movement in recent months to increase their regulation, where manufacturing and design flaws have been more of an issue. As of January 2011, the FDA had fielded 23,000 reports of manufacturing/design problems with the defibrillators over the previous 5 years.
- here's the CBC News story