BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 2443394 · Received January 19, 2012

    Report

    Report Number
    2020362-2012-00014
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Report Date
    December 7, 2011
    Manufacturer
    J. T. POSEY CO.
    Product Code
    FMQ
    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 SLIDER BROKEN). RESULTS - EVALUATION OF THE RETURNED PRODUCT FOUND THAT ON PANEL SIDE A THE ZIPPER SLIDER IS OPEN AND THE ELASTIC ON THE LOWER LEFT LEG IS BROKEN. THE WINDOW B ACCESS WINDOW HAS 1 ELEMENT MISSING. PANEL BACK SIDE THE LABEL IS RIPPED 3 INCHES. NOTE: POSEY INSTRUCTION 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 PATIENT'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 RIGHT SIDE PANELS HAVE THE SLIDER BROKEN. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY BED FMQ J. T. POSEY CO. 8060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA