BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN MEDICAL SYSTEMS SHOULDER CHAIR

    MDR report key: 681212 · Received March 1, 2006

    Report

    Report Number
    1221538-2006-00003
    Event Type
    Malfunction
    Date Received
    March 1, 2006
    Date of Event
    January 19, 2006
    Report Date
    January 31, 2006
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON SITTING AND RECLINING ON THE SHOULDER CHAIR, THE BACK OF THE CHAIR COLLAPSED, CAUSING PT TO FALL AND HIT THE LEFT POSTERIOR PORTION OF HIS HEAD ON THE FLOOR. THERE WAS NO LOSS OF CONSCIOUSNESS, C-SPINE X-RAYS AND CT SCAN WERE NEGATIVE. SURGERY WAS CANCELLED AND WAS TO BE RESCHEDULED FOR A LATER DATE AND PT WAS ADMITTED OVERNIGHT FOR OBSERVATION. HE WAS DISCHARGED HOME 1/20/06 AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEMS SHOULDER CHAIR SURGICAL TABLE ACCESSORY FWZ ALLEN MEDICAL SYSTEMS O-SC-A3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization