BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.R. DIRECT SHOULDER CHAIR

    MDR report key: 807663 · Received November 24, 2004

    Report

    Report Number
    1221538-2004-00010
    Event Type
    Malfunction
    Date Received
    November 24, 2004
    Date of Event
    October 26, 2004
    Report Date
    October 26, 2004
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A TRAINED MECHANICAL ENGINEER ON STAFF EXAMINED THE DEVICE AT THE MANUFACTURER'S FACILITY. A VISUAL INSPECTION WAS DONE AS WELL AS A PERFORMANCE TEST. THE DEVICE CONFORMED TO ALL ACCEPTANCE TESTS. NO PROBLEM WAS FOUND AND THE MALFUNCTION COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT DURING A PROCEDURE, THE CHAIR FELL FROM THE UPRIGHT TO A MORE RECLINED POSITION. THERE WAS NO IMPACT TO THE PATIENT.

    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