BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY STAYSAFE BED

    MDR report key: 2190683 · Received July 29, 2011

    Report

    Report Number
    2020362-2011-00241
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    May 24, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: EVAL OF THE RETURNED PRODUCT FOUND THAT THE PANEL SIDE A WINDOW ZIPPER SLIDER BODY IS OPEN. PANEL SIDE C LOWER LEFT LEG ELASTIC IS BROKEN. 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 THE SIDE AND FOOT PANELS HAVE ZIPPER DAMAGE. THE CUSTOMER COULDN'T PROVIDE MORE INFO ON THE SPECIFIC TYPE OF DAMAGE THERE IS TO THE ZIPPERS. THERE WAS NO PT INCIDENT OR INJURY REPORTED. INSPECTION OF THE RETURNED PRODUCT FOUND THAT THE PANEL SIDE A ZIPPER SLIDER BODY IS OPEN.

    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 NI