BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 2974761 · Received January 18, 2013

    Report

    Report Number
    2020362-2013-00025
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Report Date
    December 19, 2012
    Manufacturer
    J. T. POSEY CO.
    Product Code
    OYS
    PMA / PMN Number
    K103817
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVAL OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE THAT THE PULL TAB IS BROKEN. THE ZIPPER SLIDER BODY IS OPEN ON THE RIGHT SIDE PT ACCESS WINDOW AND PERIMETER GUARD. NOTE: POSEY INSTRUCTION FOR USE 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. INSPECT ZIPPER COILS FOR ANY KINKS OR MISALIGNMENT. TEST THAT ALL ZIPPERS OPEN EASILY AND CLOSE SECURELY AND THERE ARE NO GAPS OR OPENINGS WHEN PRESSURE IS APPLIED ALONG THE ENTIRE LENGTH OF EACH ZIPPER. ALWAYS USE ZIPPER PULL-TABS AND ENSURE THAT ZIPPERS ARE FULLY CLOSED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PULL TAB, TEETH, AND SLIDER ARE DAMAGED ON THE LEFT SIDE PANEL. THE REPORTED ISSUE WAS DISCOVERED DURING SETUP. THERE WAS NOT PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28661 POSEY BED OYS J. T. POSEY CO. 8070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA