'Voluntary Global Correction' Affects Some HeartSine AEDs
Certain Samaritan 300/300P PAD public access defibrillators made before December 2010 intermittently turn on and off, which eventually may deplete their batteries, the company announced.
FDA and HeartSine Technologies, Ltd. announced Oct. 24 that HeartSine began a "voluntary global correction" on Sept. 13, 2012, of certain Samaritan® 300/300P PAD public access defibrillators to fix two issues that may affect their ability to deliver a needed shock to someone experiencing sudden cardiac arrest. Some of the AEDs manufactured before December 2010 have been found to turn on and off intermittently, which eventually may deplete the battery, according to their identical announcements, which do not say how many units are affected.
The second problem is that some Samaritan 300/300P PAD devices "containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery and subsequently turn the device off. In certain instances, a device experiencing either condition could be unable to deliver therapy during a cardiac event," their announcements state.
No deaths or injuries have been reported as a result of the on/off issue, but the company said to date it has received five reports of deaths for which it "has not been able to rule out the possibility that the events may have been related to the battery management software issue." Consumers with questions can contact the company at 877-877-0147 from 8 a.m. to 5 p.m. Eastern or [email protected]
Units affected by this correction were manufactured from August 2004 to December 2010 and have a warranted life of seven years. Samaritan® 300/300P PAD devices with the following serial numbers inclusive are affected by one or both these issues:
- 0400000501 to 0700032917
- 08A00035000 to 10A00070753
- 10C00200000 to 10C00210106
HeartSine Technologies, Ltd. is based in Belfast, Northern Ireland, while HeartSine Technologies, Inc. is based in Newtown, Pa. The company is sending affected customers a new PAD-PAK to be held in reserve and an accompanying hang tag with instructions for when and how to insert the reserve PAD-PAK, plus HeartSine is providing a software upgrade to eliminate the second problem.
HeartSine asked customers to take the following actions to ensure that they are able to provide therapy in the event that a sudden cardiac arrest event occurs:
1. Keep the device(s) in service.
2. If necessary, relocate the Samaritan® 300/300P PAD to an area where the audible prompts would be heard if initiated.
3. Immediately increase device check frequency to daily to confirm that the Samaritan 300/300P PAD is operable and in ready standby mode.
4. If the device is not in ready standby mode, contact HeartSine Technologies at 1-877-877-0147 immediately so that a replacement unit can be sent.
5. Always have a reserve PAD-PAK on hand. Place the supplied reserve PAD-PAK in the zippered pouch on the back of the Samaritan 300/300P PAD soft carrying case and attach the provided hang tag to the handle of the Samaritan 300/300P PAD soft carrying case to alert a first responder when and how to insert the reserve PAD-PAK if the installed PAD-PAK appears to have been depleted and the device is needed in a rescue attempt. Instructions for replacing the PAD-PAK are provided on the hang tag.
6. Update the device software using the supplied data cable and CD (or via the company's website at http://www.heartsine.com/recall/software_updates). Replace the originally supplied User Manual, stored in the soft carry case, with the new copy supplied with this field action.
7. If the device is needed in a sudden cardiac arrest event and the LED is red or unlit, replace the PAD-PAK with the reserve PAD-PAK according to the instructions on the hang tag. Once the reserve PAD-PAK has been inserted, therapy can be delivered. Following the event, HeartSine Technologies should be contacted immediately at 1-877-877-0147.