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Recalls and Alerts

Medical Device Safety Alert: Nihon Kohden cardioLife defibrillator, TEC-5521K and TEC-5531K

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning a potential malfunction of cardiolife defibrillator (Model TEC-5521K and TEC-5531K) using a software version ≦ 01-20, manufactured by Nihon Kohden Corporation.

During operation the defibrillator in battery mode there are several battery alarms when reaching critical levels of the battery capacity. When the battery alarms are ignored and the battery is discharged continuously, the defibrillator shut down automatically. In rare cases this could lead to a damage of the power control circuit and the defibrillator could not turn on either in battery mode nor in AC power mode again. This defect requires maintenance of the defibrillator by the authorized service partner. The frequency of the reported incidences caused by this malfunction is approx. 0.017%.

The manufacturer advised users to make sure that the battery of the defibrillator is charged completely always and that the Battery Test and the exchange of the battery is performed regularly according the instructions in the operator’s manual and follow the instructions related to the battery alarms. This avoids the automatically shut-down of the defibrillator.

Also, the manufacturer will eliminate this potential malfunction to the affected defibrillators by the installation of a software upgrade with an improved algorithm for the automatically shut-down of the defibrillator when the battery is discharged completely. This software upgrade will be installed by the manufacturer during the next regularly maintenance.

For details, please refer to the MRHA website: http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON203860

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 14 November 2012

 
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Last Revision Date : 15 December 2012