BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY STAYSAFE BED

    MDR report key: 2112232 · Received April 29, 2011

    Report

    Report Number
    2020362-2011-00137
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    April 11, 2011
    Manufacturer
    J. T. POSEY COMPANY
    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 DAMAGE. EVAL: RESULTS: EVAL OF THE RETURNED PRODUCT FOUND THE RIGHT SIDE WINDOW PERIMETER GUARD, 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 REPORTED THAT THERE IS ZIPPER DAMAGE ON THE PRODUCT CANOPY SIDE PANEL. THE ZIPPER TEETH DO NOT CONNECT WHEN THE ZIPPER IS CLOSED. 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 COMPANY 8070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI