BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 1193085 · Received October 6, 2008

    Report

    Report Number
    2020362-2008-00008
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    August 23, 2008
    Report Date
    September 4, 2008
    Manufacturer
    J. T. POSEY CO.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED WAS FIRST EVALUATED AT THE CUSTOMER SITE. WHEN THE PRODUCT PROPERLY ZIPPED UP, THE PROBLEM COULD NOT BE DUPLICATED. POSEY REPRESENTATIVE, HOSPITAL REPRESENTATIVE, AS WELL AS PATIENT'S FAMILY COULD NOT MAKE THE ZIPPER FAIL. POSEY REPRESENTATIVE CONDUCTED TRAINING ON PROPER ZIPPER CLOSURE. THE PRODUCT WAS SUBSEQUENTLY RETURNED TO THE MFR FOR ADDITIONAL EVALUATION. VISUAL AND FUNCTIONAL TESTING CONFIRMED THAT THE ZIPPERS PERFORM AS DESIGNED. THE MOST PROBABLE ROOT CAUSE WAS THAT THE ZIPPERS WERE NOT PROPERLY CLOSED OR LEFT OPEN.

    Description of Event or Problem · 1

    PATIENT WAS PLACED IN A BED ENCLOSURE. NURSE REPORTED ZIPPER PULLED APART, AND PT ROLLED OUT OF BED. THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other