HeartSine Issues Fix For Samaritan Public Defibrillators

A global recall of Samaritan Public Access Defibrillators (PAD) was reissued by HeartSine earlier this week, updating a recall issued last year and informing customers about a fix for the faulty equipment.   

The recall of the Samaritan 300/300P PAD heart defibrillator was first issued in November 2012, when the company notified customers the battery issue affected proper functioning of the equipment. The issue may prevent users from delivering cardiac therapy to a patient during an emergency event.

HeartSine reissued the global recall statement on September 13, adding new information about an upgrade kit that may be kept near the device in case of battery problems or failure.

The action has been designed as a class 1 recall, which is the most serious type of recall and is only issued if the affected product may potentially place patients at serious risk for injury or death.

Batteries in models manufactured before 2010 may intermittently turn on and off. This can deplete the batteries prematurely, causing the software to signal a temporary drop in battery voltage. The drop in voltage signals a low battery, thus turning the device off.

An inadvertent shut down may place patients at risk if the device is unable to function during an emergency cardiac event.

The manufacturer is investigating at least six deaths that have been reported as related to the defibrillator recall, one more death than what was originally reported in November of last year. HeartSine has not been able to rule out the possibility that the deaths were related to the battery issue.

Affected devices were manufactured from August 2004 to December 2010 and were distributed globally.

The upgrade kit will include a new PAD-PAK to be kept with the device and used in emergency cases when the defibrillator battery has failed. Instructions for the PAD-PAK will also be included with the kit, along with a CD containing a software upgrade, a data cable and user manual.

The manufacturer says the defibrillator may still function correctly, making the extra replacement kit unnecessary, if the device has enough power. However they recommend keeping the kit nearby in case of an emergency and battery failure.

HeartSine recommends customers with affected models contact the company to receive the upgrade kit. The company also urges customers to check their devices daily to ensure proper functioning, relocate the device to an area where audible prompts can be heard and to keep the reserve kit on hand.

If the device is needed in an emergency cardiac event and the LED is red or unlit, replace the PAD-PAK with the reserve before using the device.

Affected devices have the serial numbers 0400000501 to 0700032917, 08A00035000 to 10A00070753, and 10C00200000 to 10C00210106. Serial numbers are located on the bottom of the device under the bar code.