BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN TABLE POWERED BEACH CHAIR

    MDR report key: 6016801 · Received October 11, 2016

    Report

    Report Number
    1221538-2016-00001
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    August 30, 2016
    Report Date
    September 13, 2016
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED FOR EVALUATION. THE EVALUATION FOUND THAT THE RIVET AT THE END OF THE RIGHT BAR, WHICH PREVENTS THE BARS FROM BEING PULLED ALL THE WAY OUT AND THE PANELS FALLING OFF, WAS MISSING. THE UNIT IS 14 YEARS OLD AND THE MOST PROBABLE CAUSE OF THE FAILURE IS WEAR AND TEAR. THIS IS THE ONLY INSTANCE OF THIS FAILURE ON THIS OR OTHER SIMILAR DEVICES MANUFACTURED BY ALLEN. A RISK ANALYSIS SHOWS THE LIKELIHOOD OF THIS FAILURE OCCURRING IS LOW AND THE FAILURE RATE IS CONSISTENT WITH THE RISK PROFILE.

    Description of Event or Problem · 1

    THE PULL BARS DID NOT LATCH WHEN BEING FULLY EXTENDED. THIS CAUSED THE SHOULDER CUSHIONS TO FALL WHICH WERE SUPPORTING THE PATIENT. PATIENT WAS SUPPORTED BY THE CAREGIVERS AS THE PULL BARS WERE PULLED OUT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670085 ALLEN TABLE POWERED BEACH CHAIR BEACH CHAIR FWZ ALLEN MEDICAL SYSTEMS, INC. A-90000-A2

    Patients

    Seq Age Sex Outcome Treatment
    1