BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY STAYSAFE BED

    MDR report key: 1935721 · Received December 16, 2010

    Report

    Report Number
    2020362-2010-00398
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Report Date
    November 30, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: EVAL FOR THE RETURNED PRODUCT SHOWS THAT THE PANEL SIDE B 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 DURING USE THERE'S ZIPPER DAMAGE ON THE LARGE ACCESS PANEL. THE ZIPPER IS BROKEN, BUT COULDN'T SPECIFY WHICH PART OF THE ZIPPER HAS DAMAGE. EVAL FOR THE RETURNED PRODUCT SHOWS THAT THE PANEL SIDE B SLIDER BODY IS OPEN. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY STAYSAFE BED FNL J. T. POSEY CO. 8050 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI