BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY STAYSAFE BED

    MDR report key: 1933143 · Received December 13, 2010

    Report

    Report Number
    2020362-2010-00396
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Report Date
    November 16, 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) - ZIPPER TEETH BROKEN. EVAL: RESULTS: EVAL FOR THE RETURNED PRODUCT SHOWS THAT THE PANEL SIDE B: WINDOW ZIPPER SLIDER BODY IS OPEN. NOTE: POSEY INSTRUCTIONS FOR USE WARNINGS: ALWAYS USE THE ZIPPER PULL-TABS WHEN OPENING OR CLOSING THE ZIPPERS. 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 CLAIMS THAT DURING SET-UP THERE IS ZIPPER DAMAGE TO THE SIDE PANEL THE TEETH ARE BROKEN. EVAL SHOWS THAT THE PANEL ZIPPER SLIDER BODY IS OPEN. THERE WAS NO PT CONTACT REPORTED.

    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 NA