BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMBERLY CLARK-BALLARD MEDICAL R-2 PAD ADAPTOR

    MDR report key: 1111809 · Received August 13, 2008

    Report

    Report Number
    MW5007977
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 17, 2008
    Report Date
    August 12, 2008
    Manufacturer
    CON MED
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PACER CABLE WITH KIMBERLY CLARK - BALLARD MEDICAL R-2 ADAPTOR IN LINE DID NOT FUNCTION PROPERLY DURING CARDIAC ARREST. THERE WAS A DELAY OF LESS THAN TWO MINUTES WHILE A SECONDARY CABLE WAS SECURED. EVALUATION BY CLINICAL ENGINEERING DETERMINED THAT THE PAD ADAPTER - THAT WAS SECURED TO THE PACER CABLE TO ALLOW USE OF A SPECIFIC PAD - WAS FAULTY CAUSING THE CABLE TO BE NON-OPERATIONAL. X-RAY OF ADAPTOR REVEALED FRACTURED WIRES IN ADAPTOR. DELAY DID NOT EFFECT PATIENT OUTCOME. TWO ADDITIONAL KIMBERLY CLARK - BALLARD MEDICAL R-2 ADAPTORS WERE FOUND TO BE NON-FUNCTIONAL DURING ROUTINE PREVENTIVE MAINTENANCE CHECKS. THEY WERE NOT INVOLVED WITH PATIENT CARE. UNABLE TO DETERMINE LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY CLARK-BALLARD MEDICAL R-2 PAD ADAPTOR DEFIBRILLATOR PAD ADAPTOR MKJ CON MED 32-170555 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR