BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 2469134 · Received February 10, 2012

    Report

    Report Number
    2020362-2012-00060
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Report Date
    December 12, 2011
    Manufacturer
    J. T. POSEY CO.
    Product Code
    FMQ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ZIPPER TEETH NOT CONNECTING. EVAL, RESULTS: EVAL OF THE RETURNED PRODUCT FOUND THAT ON PANEL B THE ACCESS WINDOW ZIPPER SLIDER BODY IS OPEN. PANEL SIDE B THE PULL TAB IS MISSING ON THE ZIPPER. WINDOW B HAS A 1 INCH HOLE IN THE NETTING. THERE IS A 1 INCH HOLE ON THE LEFT ON SIDE D AND A 1 INCH TEAR ON THE RIGHT LEG. NOTE: POSEY 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ZIPPER TEETH DO NOT CONNECT WHEN AN ATTEMPT IS MADE TO CLOSE THE LARGE ACCESS PANEL. THIS WAS DISCOVERED DURING SET UP IN THE WAREHOUSE AND THERE WAS NO PT CONTACT OR INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA