BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCLAVEABLE INTERNAL HANDLES (MSERIES)

    MDR report key: 3850342 · Received March 17, 2014

    Report

    Report Number
    1220908-2014-00654
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Report Date
    February 28, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K963781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING THE INTERNAL HANDLES CAUSED THE ASSOCIATED DEFIBRILLATOR TO FAIL SELF-TEST. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157351 AUTOCLAVEABLE INTERNAL HANDLES (MSERIES) INTERNAL PADDLE MKJ ZOLL MEDICAL CORPORATION 8011-0501-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA