BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED CABIN

    MDR report key: 2462929 · Received February 3, 2012

    Report

    Report Number
    2020362-2012-00055
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Report Date
    December 1, 2011
    Manufacturer
    J. T. POSEY CO.
    Product Code
    FMQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS: EVAL OF THE RETURNED PRODUCT FOUND ON THE PANEL SIDE A PT ACCESS WINDOW THE ZIPPER SLIDER BODY IS OPEN. ON THE MATTRESS ENVELOPE THE STITCHES ARE UNSTITCHED ONE INCH. INSERT PIN TAPE IS TORN ON THE RED ZIPPER PT ACCESS AREA. WINDOW SIDE B HAS TWO ZIPPER ELEMENTS OPEN ON THE PT ACCESS AREA. WINDOW SIDE C HAS A 1" AND 1/2" BROKEN STITCHES ON ZIPPER TAPES AREAS. NOTE: POSEY INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: NEVER TRY TO RIP A PANEL OPEN AS THIS MAY DAMAGE THE ACCESS 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. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER RETURNED THE PRODUCT WITHOUT ANY SPECIFIC INFO AS TO THE REASON FOR THE RETURN. AN ATTEMPT WAS MADE TO GET MORE INFO ON THE PRODUCTS RETURN, HOWEVER, NONE WAS AVAILABLE. THERE WAS NO PT INCIDENT OR INJURY REPORTED. INSPECTION OF THE RETURNED PRODUCT FOUND THAT THE ZIPPER SLIDER BODY IS OPEN ON A PT ACCESS WINDOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY BED CABIN FMQ J. T. POSEY CO. 8000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA