BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY STAYSAFE BED

    MDR report key: 2140701 · Received June 15, 2011

    Report

    Report Number
    2020362-2011-00211
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Report Date
    May 19, 2011
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ZIPPER COMPONENTS BROKEN. EVAL RESULTS: EVAL OF THE PRODUCT FOUND THAT THE ZIPPER SLIDER BODY IS OPEN ON PANEL SIDE A ACCESS WINDOW. (B)(4).

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED ZIPPER DAMAGE ON THE SIDE B PANEL, THE PULL-TAB AND SLIDER ARE BROKEN. THERE WAS NO PT INCIDENT OR INJURY.

    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