Safety information about LIFEPAK 12 defibrillator/monitor of the manufacturer Physio–Control Inc.
Medic d.o.o., representative of the manufacturer Physio–Control Inc., USA, a Medtronic Group member, notified the Agency for Medicinal Products and Medical Devices of a defective printed board of a LIFEPAK 12 defibrillator/monitor component. This defect may cause a short circuit on the component, which may result in no therapy delivery or in delivery of inadequate defibrillation waveforms. There have been no reported adverse events due to this defect.
The representative has notified all users and organised the replacement of the incorrect printed boards with new ones.