Dental practices have been advised to check batteries used in Schiller FRED easy defibrillators after a fault was identified that could make the devices unusable.
The Medicines and Healthcare products Regulatory Agency (MHRA) has distributed a field safety notice concerning batteries with part number 4-07-0001 and batch number HYB 26-0164.
The manufacturer identified a programming fault affecting some batteries in the batch that can cause the defibrillator to display a cell fault message and sound an alarm when the battery is installed, potentially preventing the device from being used.
Practices have been advised to check the blue label on their batteries to identify whether they are from the affected batch.
No action is required where a battery is already installed and the device’s green LED is flashing normally.
However, if the defibrillator displays a cell fault message and sounds an alarm, the battery should be removed, kept separate from usable stock and replaced.
Practices with spare batteries from the affected batch should also test them as soon as possible by inserting them into a Schiller FRED easy defibrillator and allowing the device to complete its automatic self-test.
A battery can be returned to spare stock if the green light flashes following the test. Batteries that produce an error should be removed and kept separate from usable stock.
Practices with affected batteries have been advised to contact their local Schiller distributor to arrange replacements.