Covidien—Medi-Trace Cadence Adult and Pediatric Radiotransparent Defibrillation Electrodes: Leadwire May Arc or Spark, Potentially Failing to Deliver Shock to Patient
April 17, 2013 | Risk Management News
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In an April 8, 2013, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, Covidien states that it has received customer reports of the leadwire of the defibrillation electrodes below arcing or sparking. Covidien states that the supplier of the wire/connector assembly experienced equipment damage from misalignment, which may result in the electrode leadwire arcing, sparking, or exhibiting thermal damage, potentially resulting in the electrode failing to deliver appropriate energy or shock to the patient. Covidien also states that it has received no reports of patient injury related to this problem. Owens & Minor initiated a subrecall of the above...