BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDMARK

    MDR report key: 2170744 · Received June 22, 2011

    Report

    Report Number
    1523530-2011-00018
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 21, 2011
    Manufacturer
    MIDMARK CORP.
    Product Code
    FLE
    PMA / PMN Number
    PRE-1976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE REQUESTED THAT THE STERILIZER BE RETURNED FOR EVAL, BUT HAVE NOT RECEIVED IT BACK YET.

    Description of Event or Problem · 1

    A SVC TECH WAS IN THE PROCESS OF REPAIRING THE UNIT FOR THE UNRELATED ISSUE, THEY RAN A TEST CYCLE AND THE DOOR TO THE STERILIZER OPENED UNDER PRESSURE. NO INJURIES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDMARK STEAM STERILIZER FLE MIDMARK CORP. M7-014

    Patients

    Seq Age Sex Outcome Treatment
    1