The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety notice concerning a specific batch of batteries used in Schiller FRED easy defibrillators.
The manufacturer has identified a programming fault affecting some batteries with part number 4-07-0001 and batch number HYB 26-0164. When an affected battery is installed, the device may display a cell fault message and sound an audible alarm. According to the manufacturer, the fault can make it impossible to use the defibrillator.
Check affected batteries
Practices should identify whether they hold batteries from the affected batch by checking the blue label on the battery.
No action is required for installed batteries where the green LED is flashing normally. However, if the device displays a cell fault message and emits an alarm, the battery should be replaced immediately.
Test spare batteries
Practices with spare batteries from the affected batch should test them as soon as possible. To do this, insert the battery into a Schiller FRED easy defibrillator and allow the device to complete its automatic self-test.
If the green light flashes after the test, the battery is functioning correctly and can be returned to spare stock. If the device displays an error, the battery should be removed and segregated from usable stock.
Contact your supplier
Any practice that identifies affected batteries should contact its local Schiller distributor, who will arrange replacement batteries.
Members are encouraged to review the MHRA safety notice and ensure all affected batteries are checked promptly.