BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED ALL-IN-ONE SYSTEM

    MDR report key: 1833530 · Received September 8, 2010

    Report

    Report Number
    2020362-2010-00212
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Report Date
    August 10, 2010
    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). CUT IN MATERIAL. EVAL RESULTS - EVAL OF THE RETURNED PRODUCT FOUND THAT THERE IS A FIVE INCH CUT IN THE ZIPPER TAPE ON BOTH THE MAIN WINDOW AND THE PERIMETER GUARD. THERE WAS NO ZIPPER TEETH MISSING. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THE MATERIAL APPEARS TO HAVE BEEN CUT BY A SHARP OBJECT. THE TEAR IS LOCATED ON THE MATTRESS ENVELOPE AND KEEPS GOING TO THE LEFT SIDE PANEL. ALSO, SOME TEETH ON THE ZIPPER ON THE LEFT SIDE PANEL ARE MISSING. CUSTOMER COULDN'T SPECIFY THE SIZE OF THE HOLE. THE PT WAS NOT INSIDE THE CANOPY WHEN THIS WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY BED ALL-IN-ONE SYSTEM FNL 8070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI