BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED CANOPY SYSTEM

    MDR report key: 1813258 · Received August 18, 2010

    Report

    Report Number
    2020362-2010-00177
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Report Date
    July 9, 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
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: EVALUATION FOR THE RETURNED CANOPY SHOWS THAT THE WINDOW SIDE FRONT: HAS ONE ZIPPER ELEMENT MISSING. THERE IS OTHER DAMAGE TO THE CANOPY THAT IS NOT PERTINENT TO THIS CLAIM. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THERE'S A HOLE SIZE OF A SILVER DOLLAR ON THE TOP PART OF THE MATTRESS ENVELOPE. ALSO THAT THERE MAYBE A CANOPY ZIPPER ISSUE, BUT DID NOT KNOW THE SPECIFIC LOCATION. THE PROBLEM WAS FOUND DURING SET-UP, AND THERE WAS NO PATIENT CONTACT. EVALUATION FOR THE RETURNED PRODUCT SHOWS THAT THE WINDOW SIDE FRONT IS MISSING ONE ZIPPER ELEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI