BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 3190155 · Received June 10, 2013

    Report

    Report Number
    2020362-2013-00263
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    May 29, 2013
    Manufacturer
    J. T. POSEY CO.
    Product Code
    OYS
    PMA / PMN Number
    K113355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED UNIT DID NOT CONFIRM A TEAR ON THE CANOPY, BUT DID FIND AN OPEN SLIDER BODY ON THE PT ACCESS AREA OF THE FRONT WINDOW. THE ENTIRE CANOPY IS DISCOLORED AND THERE IS DELAMINATION ON THE FRONT PANEL AND A SLIDER IS STUCK ON THE BACK WINDOW. THERE IS 2 INCHES OF BROKEN STITCHES ON THE NYLON OF WINDOW SIDE A. NOTE: INSTRUCTIONS FOR USE STATE: NEVER USE THE BED IF A ZIPPER SLIDER IS BENT OPEN OR DAMAGED AND THE ZIPPER CANNOT BE ZIPPED COMPLETELY CLOSED. REMOVE THE PT FROM THE DAMAGED BED AND EXCHANGE IT FOR A POSEY BED IN GOOD WORKING CONDITION. NEVER RIP THE PANELS OPEN, AS THIS WILL DAMAGE THE ZIPPER SLIDER, PREVENTING THE ZIPPER FROM CLOSING SECURELY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THERE IS A TEAR IN THE CANOPY. CUSTOMER IS NOT SURE OF THE LOCATION OF THE TEAR AND DID NOT PROVIDE A DATE WHEN DISCOVERED. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262142 POSEY BED OYS J. T. POSEY CO. 8060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK