BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSI FLAT TOP BED

    MDR report key: 6331514 · Received February 15, 2017

    Report

    Report Number
    6331514
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    September 21, 2016
    Report Date
    November 4, 2016
    Manufacturer
    OSI/ MIZUHO AMERICA, INC.
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT POSITIONED PRONE, SAFETY STRAPS PLACED ON PATIENT. SURGEON REQUESTED TO TILT PATIENT A SMALL DEGREE. BED LIGHTS INDICATED THAT ROTATION WAS SAFE TO PROCEED. WHEN THE REMOTE WAS TOUCHED, BED WENT INTO FREE ROTATION AND WENT TO A 90 DEGREE POSITION TO THE FLOOR ON ITS OWN. THE GEARS JUST GAVE AWAY, REQUIRING THE NURSE, PHYSICIAN AND REP TO HOLD THE BED IN A PRONE PATIENT POSITION UNTIL HELP ARRIVED. NO PATIENT INJURY. UPON ARRIVAL IN BIOMED, BED WAS CONNECTED AND FOUND POWER ENTRY MODULE LOOSE, SPLASH GUARD TORN ON ON/OFF SWITCH, HEAD END CASTER RIGHT SIDE DEMONSTRATED WIGGLE. BED FAILED 5-3 ABLE TO MOVE CROSSBAR WHEN LAMP IS ON, 5-5- FAILED 95 FR CHECK. THIS BED WAS RECENTLY NEW AND STILL UNDER WARRANTY. FIRST PREVENTATIVE MAINTENANCE DUE LATER THIS YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116700 OSI FLAT TOP BED TABLE, OPERATING-ROOM, ELECTRICAL GDC OSI/ MIZUHO AMERICA, INC. 9655

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR NO OTHER THERAPIES