BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCLAVABLE INTERNAL HANDLES (MSERIES)

    MDR report key: 2982231 · Received July 5, 2006

    Report

    Report Number
    1220908-2006-01327
    Event Type
    Malfunction
    Date Received
    July 5, 2006
    Date of Event
    June 9, 2006
    Report Date
    June 13, 2006
    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

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A F/U REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THE DEVICE FAILED TO DISCHARGE WHILE TREATING A PT. THERE WAS NO ADVERSE AFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCLAVABLE INTERNAL HANDLES (MSERIES) INTERNAL PADDLE LDD ZOLL MEDICAL CORPORATION 5011-0501-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK