BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCLAVABLE INTERNAL HANDLES (MSERIES)

    MDR report key: 1000555 · Received February 15, 2008

    Report

    Report Number
    1220908-2008-00324
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Report Date
    January 30, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED MALFUNCTION WAS OBSERVED ATTRIBUTED TO A FAULTY DISCHARGE BUTTON. THE CUSTOMER RECEIVED A REPLACEMENT SET OF HANDLES.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING SET-UP OF THE DEVICE PRIOR BEING USED ON A PT THE DEVICE SUCCESSFULLY DELIVERED THREE SHOCKS, HOWEVER, ON THE FOURTH ATTEMPT THE DEVICE WOULD NOT ALLOW DISCHARGE. 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 (MSERIES) INTERNAL PADDLE LDD ZOLL MEDICAL CORPORATION 8011-0501-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA