BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAYSAFE BED

    MDR report key: 2423444 · Received January 13, 2012

    Report

    Report Number
    2020362-2012-00013
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Report Date
    November 2, 2011
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - MOLD. EVAL, RESULTS: EVAL OF THE RETURNED PRODUCT FOUND THAT ON PANELS A AND B THE MAIN ACCESS WINDOWS HAVE OPEN ZIPPER SLIDER BODIES. THE PANEL A RED CONNECTING ZIPPER HAS MOLD ON IT AND WINDOW SIDE C ZIPPER HAS BROKEN STITCHES. 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. 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 THAT THERE ARE TRACES OF MOLD ON THE TAPE OF THE ZIPPER. THE CUSTOMER REPORTED TO HAVE LAUNDERED THE CANOPY PER INSTRUCTIONS AND THE MOLD REMAINS. THE CUSTOMER WOULD LIKE THE TAPE AND ZIPPER REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA