BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERIS

    MDR report key: 2663053 · Received February 23, 2010

    Report

    Report Number
    2663053
    Event Type
    Injury
    Date Received
    February 23, 2010
    Date of Event
    February 3, 2010
    Report Date
    February 3, 2010
    Manufacturer
    STERIS CORP.
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OPERATING ROOM TABLE (STERIS 4085) MALFUNCTIONED WITH PATIENT ON IT DURING SURGERY. TABLE CONTINUED TO FOLD INTO A HIGH FOWLERS POSITION REGARDLESS OF WHICH BUTTON THE ANESTHESIOLOGIST PUSHED. A STERIS MAINTENANCE PERSON WAS IN FACILITY AND WAS CALLED TO ASSIST. THE STERIS REP STATED THAT THE MANUAL OVERRIDE WOULD NOT WORK. BED CONTINUED TO MOVE INTO HIGH FOWLERS POSITION DURING OVERRIDE. PATIENT WAS ABLE TO BE MOVED TO ANOTHER OPERATING ROOM TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS 4850 OPERATING ROOM TABLE FWZ STERIS CORP. 4850 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention