BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY STAYSAFE BED

    MDR report key: 2192577 · Received June 30, 2011

    Report

    Report Number
    2020362-2011-00221
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Report Date
    May 10, 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) - TEARS, RIPS, IN NETTING MATERIAL. EVALUATION RESULTS: EVALUATION OF THE RETURNED CANOPY SHOWS THAT THE PATIENT ACCESS PANEL SIDE RIGHT: MOLDING ZIPPER SLIDER BODY IS OPEN. NOTE: POSEY INSTRUCTIONS FOR USE WARNING INDICATES: NEVER USE THE BED IF A ZIPPER SLIDER IS BENT OPEN OR DAMAGED AND THE ZIPPER IS NOT SECURELY CLOSED. TEST THAT ALL OF THE ZIPPERS OPEN EASILY AND CLOSE SECURELY ALONG THE ENTIRE LENGTH OF THE ZIPPER. NEVER TRY TO RIP A PANEL OPEN AS THIS MAY DAMAGE THE ACCESS PANEL OR THE ZIPPER SLIDER BY BENDING IT OPEN. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THERE IS A TEAR ON THE CANOPY MATERIAL. CUSTOMER DID NOT SPECIFY THE LOCATION OR THE SIZE OF THE TEAR. CUSTOMER NOTED RIP COVER ON THEIR RETURN SERVICE FORM. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY STAYSAFE BED FNL J. T. POSEY CO. 8070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA