BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY STAYSAFE BED

    MDR report key: 1933987 · Received December 1, 2010

    Report

    Report Number
    2020362-2010-00386
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Report Date
    November 8, 2010
    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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (ZIPPER DAMAGE). EVALUATION: RESULTS: EVALUATION OF THE PRODUCT FOUND THAT THE FRONT SIDE WINDOW ZIPPER IS DAMAGED. WHEN THE ZIPPER IS CLOSED, THE ELEMENTS SEPARATE WHEN THE ZIPPER IS TWISTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SIDE PANEL HAS A ZIPPER THAT HAS DAMAGE BUT COULDN'T PROVIDE MORE INFORMATION ABOUT THE SPECIFIC ZIPPER DAMAGE. THIS WAS DISCOVERED WHILE IN USE; HOWEVER, THERE WAS NO PATIENT INCIDENT OR INJURY THAT OCCURRED. INSPECTION OF THE PRODUCT FOUND THAT THE FRONT WINDOW ZIPPER SEPARATES WHEN TWISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY STAYSAFE BED FNL J. T. POSEY CO. 8040 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI