BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMSCO

    MDR report key: 2250758 · Received September 7, 2011

    Report

    Report Number
    2250758
    Event Type
    Malfunction
    Date Received
    September 7, 2011
    Date of Event
    June 9, 2011
    Report Date
    August 18, 2011
    Manufacturer
    STERIS CORPORATION
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    OR TEAM WAS READY TO BEGIN THE PROCEDURE & MAKE THE FIRST INCISION. AT THIS TIME, THE TABLE STARTED CYCLING FROM REVERSE TRENDELENBURG TO TRENDELENBURG. THE TEAM SURROUNDED THE TABLE AND WAS HOLDING THE PATIENT TO PREVENT HIM FROM SLIDING OFF THE TABLE. FIRST THE TEAM TRIED TO CONTROL THE TABLE WITH THE HAND CONTROLLER, BUT IT CONTINUED TO MOVE ON ITS OWN. THERE IS ANOTHER PANEL FOR CONTROLLING THE TABLE, WHICH IS NOT A FAMILIAR CONTROL FOR OR STAFF. OR TECH WAS OVERHEAD PAGED WITHIN OR TO GO TO THE ROOM. THE TABLE WAS STILL CYCLING. THE OR TECH TRIED TO USE THE MANUAL CONTROLS UNDER THE TABLE, BUT IT WOULD NOT RESPOND. IT IS NOTED THAT THE OR TECH SAW LIQUID UNDER THE TABLE. THE TEAM UNPLUGGED THE TABLE AND THE BATTERY KEPT THE TABLE CYCLING OUT OF CONTROL UNTIL THE BATTERY LOST ITS CHARGE (APPROX 10 MINUTES).====================== MANUFACTURER RESPONSE FOR 3085 BATTERY-POWERED 120V TABLE, I/A COMPATIBLE TABLETOP WITH 2IN TLT PADS AND X-RAY TOP, (BRAND NOT PROVIDED) (PER SITE REPORTER)======================THE SERVICE REP INFORMED ME THAT THE CAUSE OF THE SHORTAGE WAS NOT CAUSED BY WATER. THE SWITCH MALFUNCTIONED. IT WAS REPLACED. HOWEVER, THE UNIT MALFUNCTIONED AGAIN, ACCORDING TO THE SURGICAL TECH. IT GOT STUCK IN THE UP POSITION. TWO OF THE HOSPITAL'S BIOMED TECHS REPLACED A CORD AND IT WAS DEEMED REPAIRED. THE BED IS BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMSCO 3085 BATTERY-POWERED 120V TABLE, I/A COMPATIBLE TABLETOP WIT GDC STERIS CORPORATION AMSCO 3085 SP *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR