BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.R. DIRECT SHOULDER CHAIR

    MDR report key: 603306 · Received May 13, 2005

    Report

    Report Number
    1221538-2005-00005
    Event Type
    Malfunction
    Date Received
    May 13, 2005
    Date of Event
    April 13, 2005
    Report Date
    April 14, 2005
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CHAIR BACK FELL FROM AN UPRIGHT POSITION TO A MORE RECLINED POSITION DURING A PROCEDURE. THERE WAS NO IMPACT TO THE PT. WHEN THE CHAIR WAS UNDRAPED BY THE STAFF FOLLOWING THE PROCEDURE ALL THE CLAMPS APPEARED TO BE TIGHT AND NO MALFUNCTION COULD BE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O.R. DIRECT SHOULDER CHAIR PATIENT POSITIONING DEVICE FWZ ALLEN MEDICAL SYSTEMS, INC. O-SC-A4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention