BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 3060671 · Received March 28, 2013

    Report

    Report Number
    2020362-2013-00138
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    March 1, 2013
    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: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE. EVALUATION REVEALED THAT THE PATIENT ACCESS RIGHT WINDOW SLIDER BODY IS OPEN AND THE ZIPPER PULL TAB IS MISSING. NOTE: POSEY INSTRUCTIONS FOR USE WARNING STATES: 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 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. ALWAYS USE ZIPPER PULL-TABS AND ENSURE THAT ZIPPERS ARE FULLY CLOSED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE ZIPPER IS BROKEN ON THE RIGHT SIDE PANEL. NO PATIENT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127259 POSEY BED OYS J. T. POSEY CO. 8070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK