BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 3063822 · Received April 3, 2013

    Report

    Report Number
    2020362-2013-00142
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    February 18, 2013
    Manufacturer
    J. T. POSEY CO.
    Product Code
    OYS
    PMA / PMN Number
    K113355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT DID NOT CONFIRMED THE REPORTED ISSUE: NO ZIPPER "PULLS" WERE FOUND TO BE BROKEN. HOWEVER, ON PANEL SIDE B WINDOW ACCESS ZIPPER SLIDER BODY IS OPEN. ON PANEL SIDE A WINDOW ZIPPER SLIDER IS MISSING. PANEL SIDE A HAS 1 INCH BROKEN STITCHES ON THE RED ZIPPER TAPE. WINDOW B HAS A 2 INCH TEAR IN THE NETTING. PANEL SIDE D LEFT LEG ZIPPER SLIDER AND RETAINING BOX IS MISSING. NOTE: 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. INSPECT ZIPPER COILS FOR NAY KINKS OR MISALIGNMENT. TEST THAT ALL ZIPPERS OPEN EASILY AND CLOSE SECURELY AND THERE ARE NO GAPS OR OPENING 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

    THE CUSTOMER REPORTED THE ZIPPER "PULLS" ARE BROKEN. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135407 POSEY BED OYS J. T. POSEY CO. 8060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA