The U.S. Food and Drug Administration has issued a Class 1 recall for certain models of the HeartSine Samaritan 300/300P Public Access Defibrillator.
According to the FDA, the problematic models were manufactured and distributed from August, 2004, through January, 2011.
The problems with the devices are twofold.
Some of the devices have been found to intermittently turn on and off, which may eventually deplete the battery. Also, certain devices that contain early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery, resulting in the device turning itself off.
With either problem, the defibrillators may be unable to perform during a cardiac emergency.
HeartSine received five reports of death where the company has been unable to rule out the possibility that the battery management software problem was the cause. No deaths or injuries related to the on/off problem have been reported.
Class 1 recalls are the most serious kind, and apply to situations in which there is a reasonable probability that use of the recalled products will cause serious adverse health problems or death.
The recall applies to devices with the following serial numbers:
- 0400000501 to 0700032917
- 08A00035000 to 10A0070753
- 10C00200000 to 10C00210106
See the FDA’s recall notice here:
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm328604.htm
