BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILIZER

    MDR report key: 5084582 · Received April 19, 2004

    Report

    Report Number
    5084582
    Event Type
    Malfunction
    Date Received
    April 19, 2004
    Date of Event
    December 1, 2003
    Report Date
    February 1, 2004
    Manufacturer
    GETINGE USA, INC.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POWER FAILURE OCCURRED AND STERILIZATION DEVICE DID [NOT] REPROGRAM ITSELF AS IT SHOULD HAVE RESULTING IN THE TWO LOADS FOLLOWING THE POWER FAILURE [NOT GETTING] STERILIZED AT THE PROPER TEMPERATURE. ALL ITEMS WERE ABLE TO BE RECALLED EXCEPT FOR TWO BASINS AND ARTHROBASKET. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILIZER STERILIZER FLE GETINGE USA, INC. N/C 3633

    Patients

    Seq Age Sex Outcome Treatment
    1