BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 3131642 · Received May 6, 2013

    Report

    Report Number
    2020362-2013-00201
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    J. T. POSEY CO.
    Product Code
    OYS
    PMA / PMN Number
    K103817
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: EVALUATION OF THE RETURNED BED CONFIRMED THE REPORTED ISSUE; INSPECTION OF THE BED INDICATES THAT THE ZIPPER WAS SEWN INCORRECTLY ON THE HEAD SIDE PATIENT WINDOW ZIPPER. THE ZIPPER WAS SEWN FROM LEFT TO RIGHT AND WAS SECURED TO THE RIGHT SIDE OF THE CANOPY WHICH WOULD BE VISIBLE TO THE PATIENT FROM THE INSIDE. THE ZIPPER IS DESIGNED TO OPEN FROM RIGHT TO LEFT AND THE ZIPPER IS SECURED ON THE TOP OF THE LEFT SIDE WHERE THE ZIPPER WOULD NOT BE VISIBLE TO THE PATIENT ON THE INSIDE OF THE CANOPY. THE PULL TAB IS BROKEN OFF OF THE ZIPPER BODY AND IS MISSING AS REPORTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PATIENT WAS ABLE TO MANIPULATE THE ZIPPER ON THE RIGHT SIDE PANEL AND GET OUT OF THE UNIT. THE PATIENT WAS ABLE TO RELEASE HIMSELF THROUGH THE HEAD PANEL, GOT OUT OF THE UNIT, LOWERED HIMSELF TO THE FLOOR AND IN THE PROCESS THE PULL TAB BROKE OFF. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197904 POSEY BED OYS J. T. POSEY CO. 8070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK