HPRA issues safety notice for Zoll defibrillator model
The Health Products Regulatory Authority (HPRA) has issued a safety notice affecting a Zoll Powerheart defibrillator model which warns that the device may not deliver therapy when needed.
The notice refers to the Zoll Powerheart G5 AED which, the HPRA says, may display Error Code (EC) 501 and may be unable to deliver lifesaving therapy while in this state.
The issue can be detected during routine inspection, it said.
If the error code is detected, the manufacturer Zoll has advised that the device be removed from use.
Zoll said it is aware of one adverse event where a patient died as a result of the device failing due to the specific error code outlined.
The HPRA said users should replace the device before it is needed in an emergency situation.
Users are urged to follow instructions provided by the manufacturer in a field safety notice issued in relation to the matter.
The manufacturer said the rate of acknowledgment from users in Ireland to date has been low.
Users of Powerheart G5 devices are also urged to ensure their organisation has a system in place for regular monitoring of devices.
Zoll said that the likely cause of the error code is exposure to humidity outside the device's published specification.
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