The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device field safety concerning Medi-Trac Cadence Adult (Product ID 22550R)and Pediatric (Product ID 22550P) Radiotransparent Defibrillation Electrodes, manufactured by Covidien. The affected lot numbers are as follows:
Covidien has received customer reports of arcing/sparking on the defibrillation electrode lead wire. The manufacturer has become aware that the vendor who supplies Covidien with the wire/connector subassembly experienced equipment damage due to misalignment from tooling installed in Aug 2012. This could result in arcing, sparking, or thermal damage to the lead wire, which could render the device incapable of delivering the appropriate energy or shock to the patient.
According to the local supplier, the affected products were not distributed in Hong Kong.
For details, please refer to MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON261823
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 April 2013