HPRA: More Than 900 Defibrillators May Fail to Work in Emergency

Ireland’s Health Products Regulatory Authority is urging organizations — including schools, shopping centers and restaurants — to ensure their automated external defibrillators have undergone safety and maintenance updates after determining that more than 900 may not work as intended.

Specifically, roughly 940 AEDs in Ireland made by three manufacturers have not had an important corrective action completed. “We know that the manufacturers concerned have attempted to contact the owners directly with some also using national advertising to highlight the importance of carrying out the required upgrade or battery check,” says Anne Tobin, HPRA’s medical devices vigilance manager, in a prepared statement.

The models are: Physio Control’s Lifepak CR Plus and Lifepak 1000, Zoll’s AED Plus, and HeartSine’s Samaritan PAD, 300, 300P and Samaritan 500P.

The HPRA advises owners of these AEDs to respond to requests from the manufacturer or supplier of their device. The owners also should ensure manufacturers have their correct contact details to keep them informed of necessary safety upgrades.

In addition, the HPRA warns that weather temperatures will affect a defibrillator’s performance, and all AED devices should be stored correctly and regularly checked during over the winter.

AEDs recently have been a source of safety concerns. Between January 2005 and September of last year, the FDA received 72,000 adverse event reports involving the devices. During the same period, manufacturers staged 111 recalls involving more than 2 million AEDs, many of which were due to design and manufacturing issues.

In January of this year, the FDA issued a final order to require the filing of premarket approval applications for AEDs. (IDDM, Jan. 30).
— Jonathon Shacat