Safety information about LIFEPAK 12 defibrillator/monitor of the manufacturer Physio–Control Inc.
10.04.2009
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.
An excessive quantity of solder on certain electric cable joints 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.
In the Republic of Croatia, four emergency medicine facilities use the above mentioned LIFEPAK 12 defibrillator/monitors.
The representative has notified all users and provided them with instructions to perform a user test, which may detect this failure in time. Service engineers will visit all users within 30 days and replace the incorrect printed boards with new ones.
