BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 2462930 · Received February 3, 2012

    Report

    Report Number
    2020362-2012-00056
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Report Date
    December 21, 2011
    Manufacturer
    J. T. POSEY CO.
    Product Code
    FMQ
    PMA / PMN Number
    K103817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS: EVAL OF THE RETURNED PRODUCT FOUND ON THE RIGHT SIDE WINDOW ZIPPER BODY IS OPEN AND THREE ZIPPER ELEMENTS ARE OPEN. THE TOP RIDGE ZIPPER PULL TAB IS MISSING. THERE IS A 1 INCH NETTING TEAR IN THE RIGHT WINDOW. NOTE: POSEY INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: NEVER TRY TO RIP A PANEL OPEN AS THIS MAY DAMAGE THE ACCESS OR THE ZIPPER SLIDER BY BENDING IT OPEN. NEVER USE THE BED IF A ZIPPER SLIDER IS BENT OPEN OR DAMAGED, AS THIS MAY PREVENT THE ZIPPER FROM CLOSING SECURELY. NEVER LEAVE THE PT'S BEDSIDE UNTIL ALL ACCESS PANEL ZIPPERS ARE SECURELY CLOSED. TEST THE ENTIRE LENGTH OF EACH ZIPPER BY PRESSING AGAINST THE PANEL NEAR THE ZIPPER TO MAKE SURE IT IS SECURELY CLOSED AND THE ACCESS PANEL WILL NOT OPEN WHEN PRESSURE IS APPLIED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THERE IS A HOLE ON THE RIGHT SIDE PANEL. THE SIZE OF THE HOLE WAS NOT REPORTED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA