BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY STAYSAFE BED

    MDR report key: 2140703 · Received June 15, 2011

    Report

    Report Number
    2020362-2011-00208
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Report Date
    May 16, 2011
    Manufacturer
    J. T. POSEY CO.
    Product Code
    FNL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: EVALUATION OF THE PRODUCT FOUND THAT PANEL SIDE A ACCESS WINDOW ZIPPER SLIDER BODY IS OPEN. WINDOW SIDE B ZIPPER TAPE HAS 1/4 INCH BROKEN STITCHES. THERE IS MOLD AND INK STAINS ON THE CANOPY AND NETTING MATERIAL. 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 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 PANEL WILL NOT OPEN WHEN PRESSURE IS APPLIED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ZIPPER DAMAGE TO THE SIDE PANEL, WHEN AN ATTEMPT IS MADE TO CLOSE THE ZIPPER, THE TEETH DO NOT ALIGN. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA