BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMBERLY CLARK-BALLARD MEDICAL R-2 PAD ADAPT

    MDR report key: 1250622 · Received August 29, 2008

    Report

    Report Number
    1250622
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    July 17, 2008
    Report Date
    August 27, 2008
    Manufacturer
    MERIT CABLES, INC.
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT "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." EVAL BY CLINICAL ENGINEERING DETERMINED THAT THE PAD ADAPTOR, THAT WAS SECURED TO THE PACER CABLE TO ALLOW USE OF A SPECIFIC PAD, WAS FAULTY CAUSING THE CABLE TO BE NON-OPERATIONAL. DELAY DID NOT AFFECT PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY CLARK-BALLARD MEDICAL R-2 PAD ADAPT DEFIBRILLATOR PAD ADAPTOR MLN MERIT CABLES, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR