BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMBERLY CLARK-BALLARD MEDICAL R-2 PAD ADAPT

    MDR report key: 1160770 · Received September 8, 2008

    Report

    Report Number
    1320894-2008-00129
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    August 8, 2008
    Report Date
    September 4, 2008
    Manufacturer
    MERIT CABLES, INC
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS FOUND BY CONMED REPRESENTATIVES ON 08/22/08 AT THE FACILITY. DEVICE HAS BEEN RETURNED TO CONMED FOR INVESTIGATION. WHEN THE ENGINEERS REPORT HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "ONE ADAPTOR HAD NO CONDUCTIVITY FOUND WHEN CONMED REP VISITED THE FACILITY".

    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