BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY STAYSAFE BED

    MDR report key: 2000097 · Received February 3, 2011

    Report

    Report Number
    2020362-2011-00028
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Report Date
    October 13, 2010
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - CANOPY FITTING TIGHT AROUND THE FRAME. EVALUATION: RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE ZIPPER SLIDER BODY IS OPEN ON THE PANEL SIDE A MAIN ACCESS WINDOW. 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMS THAT THE MATERIAL OF THE BED CANOPY IS FITTING EXTREMELY TIGHT AROUND THE FRAME AND THIS IS PRODUCING TENSION CAUSING THE ZIPPER TO DROP DOWN. THE CUSTOMER DID NOT REPORT ANY INCIDENT OR INJURY TO THE PT. INSPECTION OF THE RETURNED PRODUCT FOUND THAT ON PANEL SIDE A MAIN ACCESS WINDOW THE ZIPPER SLIDER BODY IS OPEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI