Medical device manufacturer, GS Elektromedizinische Geräte, has issued a medical device safety alert concerning its Defibrillator-/pacer unit corpuls3 SLIM [P/N 04301] and Defibrillator-/pacer unit corpuls3 Touch SLIM [P/N 04302]. [Production Date: Jan 2020- April 2021, Serial no.: multiple]
Due to high mechanical strain on the medical device mentioned above, caused e.g. by the device falling down, this can result in malfunction or failure of the high voltage unit. When performing a defibrillation, the affected device shows the alarm message "Shock aborted". Shock release may then no longer be possible and no therapy can be performed on the patient.
In case of high mechanical strain, the manufacturer recommends to perform the function test immediately, as described in the user manual chapter 10.2.1. Daily check must be performed at least once a day or at the start of a shift. If daily check in manual mode cannot be performed, the daily check in AED mode is recommended. If the described alarm message is issued during the function check, the measures in chapter 11 of the user manual have to be performed. According to the manufacturer, a permanent correction of the malfunction is only possible by exchanging the affected high voltage unit by an authorised sales and service partner.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 6 Aug 2021