BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY STAYSAFE BED

    MDR report key: 2140705 · Received June 15, 2011

    Report

    Report Number
    2020362-2011-00217
    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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ZIPPER TEETH WON'T CONNECT. EVALUATION RESULTS: EVALUATION OF THE PRODUCT FOUND THAT ON THE ACCESS WINDOW OF PANEL SIDE B, BOTH ZIPPER SLIDER BODIES ARE OPEN. WINDOW SIDE A HAS 1 INCH BROKEN STITCHES ON THE ZIPPER TAPE. WINDOW B HAS TWO HOLES IN THE NETTING. PANEL SIDE B INSERT PIN IS RIPPED FROM THE TOP RIDGE ZIPPER. 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 THAT THE CANOPY HAS A ZIPPER SLIDER THAT IS BROKEN AND DOES NOT CONNECT THE TEETH ON PANEL SIDE A. 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. 8060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI