BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERNAL PADDLE, 1400

    MDR report key: 1993648 · Received January 26, 2011

    Report

    Report Number
    1220908-2011-00092
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Report Date
    January 5, 2011
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    LDD
    PMA / PMN Number
    K932028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING TRAINING BY FACILITY STAFF, THE DEVICE FAILED TO ALLOW THE ASSOCIATED DEFIBRILLATOR TO DISCHARGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERNAL PADDLE, 1400 INTERNAL PADDLE LDD ZOLL MEDICAL CORPORATION 8004-0049 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA