BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY STAYSAFE BED

    MDR report key: 1914048 · Received November 19, 2010

    Report

    Report Number
    2020362-2010-00370
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Report Date
    October 28, 2010
    Manufacturer
    J. T. POSEY CO.
    Product Code
    FNL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO PATIENT INVOLVEMENT, (B)(4) - ZIPPER SLIDER IS BROKEN AND TEETH DO NOT ALIGN. RESULTS: EVALUATION OF THE PRODUCT FOUND THAT THE PANEL SIDE A WINDOW ZIPPER SLIDER BODY IS OPEN. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ZIPPER IS DAMAGED ON THE SIDE PANEL A THAT THE SLIDER IS BROKEN AND THE TEETH DO NOT ALIGN. THIS WAS DISCOVERED DURING SET UP AND THERE WAS NO PATIENT CONTACT. INSPECTION OF THE PRODUCT FOUND THAT THE PANEL SIDE A ZIPPER SLIDER BODY IS OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY STAYSAFE BED FNL J. T. POSEY CO. 8060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA