BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY STAYSAFE BED

    MDR report key: 1904073 · Received November 12, 2010

    Report

    Report Number
    2020362-2010-00345
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Report Date
    October 15, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - EVAL OF THE PRODUCT FOUND THAT THE PANEL SIDE B WINDOW ZIPPER SLIDER BODY IS OPEN. THERE WAS NO EVIDENCE OF ANY ZIPPER TEETH MISSING. NOTE: POSEY INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: 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

    THE CUSTOMER REPORTED THAT THERE IS ZIPPER DAMAGE ON THE CANOPY, THE TEETH ARE MISSING BUT COULDN'T SPECIFY WHERE. THERE WAS NO PT INCIDENT OR INJURY REPORTED. INSPECTION OF THE PRODUCT SHOWS THAT ON PANEL SIDE B ACCESS WINDOW THE ZIPPER SLIDER BODY IS OPEN.

    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