BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OR DIRECT SHOULDER CHAIR

    MDR report key: 5351934 · Received September 10, 2004

    Report

    Report Number
    1221538-2004-00005
    Event Type
    Malfunction
    Date Received
    September 10, 2004
    Date of Event
    August 4, 2004
    Report Date
    August 16, 2004
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT STATED THAT DURING A PROCEDURE THE BACK SUPPORT SUDDENLY DROPPED FROM AN UPRIGHT TO A FLAT POSITION. THE ANESTHESIOLOGIST CAUGHT THE BACK AS IT WAS FALLING DOWN. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OR DIRECT SHOULDER CHAIR BEACH CHAIR POSITIONING DEVICE FWZ ALLEN MEDICAL SYSTEMS, INC. O-SC NA

    Patients

    Seq Age Sex Outcome Treatment
    1