BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY STAYSAFE BED

    MDR report key: 2112250 · Received April 29, 2011

    Report

    Report Number
    2020362-2011-00122
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    March 31, 2011
    Manufacturer
    J. T. POSEY COMPANY
    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 RETURNED PRODUCT FOUND THAT THE FRONT SIDE PANEL ACCESS ZIPPER SLIDER BODY IS OPEN. THE FRONT SIDE WINDOW NETTING HAS A 1/4 INCH HOLE. THE ELASTIC IS BROKEN ON THE UPPER AND LOWER ELASTIC ENDS OF THE LEGS AND TOP RIDGE AREAS. THE EVALUATION FINDINGS ARE CONSISTENT WITH THAT OF USER HANDLING RELATED ISSUES AS NOTED IN THE POSEY INSTRUCTIONS FOR USE WHICH 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. MANUFACTURER REFERENCES FILE (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMS THERE IS A TEAR IN THE NETTING; HOWEVER, THEY WERE NOT SURE OF THE LENGTH AND CAUSE OF THE TEAR. 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 COMPANY 8040 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI