Zoll Medical Corp. (NSDQ:ZOLL) is reminding customers about defective batteries and a software glitch in one of its defibrillators that may have killed two people.
In April, the Chelmsford, Mass.-based resuscitation device maker issued a “voluntary worldwide field corrective action” on its AED Plus automated external defibrillator after discovering the problem.
Batteries in some of the devices made before Feb. 12 are defective and the software in the debrillators that’s supposed to detect such problems doesn’t work properly, the company said at the time. The roughly 180,000 affected devices carry serial numbers below “X_ _ _200000,” according to the warning, and defibrillators older than three years — about 80,000 of them — are the most likely to fail.
On Dec. 21 Zoll issued a reminder about the problem, saying customers who haven’t run a software upgrade and notified the company must do so immediately.
The problem initially came to light from customer reports, according to a press release, and “there has been one clinical event reported in which a defibrillation shock was not delivered [and] the patient subsequently died.”
A subsequent review found that three other devices failed and, in one of those instances, a second patient later died.
The software defect can be fixed with a patch, available for download from the company’s website, that can detect defective batteries and alert users.
Zoll said customers should take the following actions:
- All AED Plus devices with serial numbers below “X_ _ _200000” must be upgraded with the latest software release. The software update can be easily downloaded from the company’s web site and installed by the user.
- Users must send Zoll an acknowledgement that the corrective action has been implemented after updating the device software. This confirmation is required for customers to avoid liability and for Zoll to ensure defective devices have been remedied.