BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY STAYSAFE BED

    MDR report key: 1935726 · Received December 16, 2010

    Report

    Report Number
    2020362-2010-00403
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Report Date
    November 22, 2010
    Manufacturer
    J. T. POSEY CO.
    Product Code
    FNL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: EVAL OF THE RETURNED PRODUCT FOUND THAT THE PANEL SIDE A THE WINDOW ZIPPER SLIDER BODY IS OPEN. THERE IS A 1 INCH HOLE ON THE MATTRESS ENVELOPE AND A 1 INCH HOLE ON THE LITERATURE BAG. NOTE: POSEY INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: NEVER TRY TO RIP A PANEL OPEN AS THIS MAY DAMAGE THE ACCESS PANEL OR THE ZIPPER SLIDER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMS THAT THE ZIPPERS ARE MISSING ON THE FRONT PANEL OF THE CANOPY. THERE WAS NO PT INCIDENT OR INJURY REPORTED. INSPECTION OF THE RETURNED PRODUCT FOUND THAT ON PANEL A THE WINDOW 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 NI