BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCLAVABLE INTERNAL HANDLES, MOLDED

    MDR report key: 2883432 · Received November 13, 2012

    Report

    Report Number
    1220908-2012-03058
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    LDD
    PMA / PMN Number
    K032691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO DETECT THE ATTACHED PADDLES. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCLAVABLE INTERNAL HANDLES, MOLDED AUTOCLAVABLE INTERNAL HANDLES, MOLDED LDD ZOLL MEDICAL CORPORATION 1011-0140-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA