BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 4180366 · Received October 15, 2014

    Report

    Report Number
    2020362-2014-00332
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 9, 2014
    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
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION FOUND THAT THE LEFT SIDE PT ACCESS ZIPPER SLIDER BODY WAS FOUND TO BE OPEN AND OUT OF MANUFACTURING SPECIFICATIONS, WHICH CAN CONTRIBUTE TO PREVENTING THE SLIDER FROM PROPERLY ENGAGING THE ZIPPER TEETH. IN AREAS WHERE THE SLIDER IS ABLE TO ENGAGE THE ZIPPER TEETH, THE ZIPPER CHAIN CANNOT BE OPENED. THE CAUSE OF THE OPEN SLIDER BODY AND MISSING PULL TAB IS LIKELY EXCESSIVE FORCE BEING APPLIED TO THE PULL TAB. THE LEFT SIDE WINDOW ZIPPER SLIDER PULL TAB IS MISSING AND THE KEY-RING THAT CONNECTS THE PULL TAB TO THE QUICK RELEASE BUCKLE HAD BEEN LOOPED THROUGH THE CROWN OF THE SLIDER WHERE THE PULL TAB SHOULD CONNECT. THE OBSERVED "LOOPING" OF THE RING THROUGH THE SLIDER CROWN IS AN UNAUTHORIZED MODIFICATION OF THE DEVICE. THERE ARE TWO HOLES IN THE FABRIC ALONG THE OUTSIDE MATTRESS SEAM AND INSIDE OF THE BOLSTER BAG. ONE OF THE RIGHT SIDE SOFT-RAIL BUCKLES IS MISSING. A BROKEN TOOTH WAS FOUND AT THE RIGHT SIDE HEAD CROSS-BAR SEAM. THERE WAS NO TOOTH DAMAGE ALONG THE PT ACCESS PANEL. DELAMINATION OF THE MATTRESS COMPARTMENT WAS OBSERVED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE RESIDENT FELL OUT OF A POSEY BED. WHEN THE RESIDENT WAS PLACED IN THE BED, THE ZIPPERS AN SAFETY CLIPS WERE SECURED. CUSTOMER REPORTED THAT UPON VIDEO SURVEILLANCE, THE RESIDENT IS SEEN LEANING AGAINST THE INSIDE OF THE MESH ON THE LEFT SIDE OF THE BED. AFTER SEVERAL MINUTES, SHE APPEARS TO GET A SMALL GAP IN THE ZIPPER, AND THEN PROCEEDS TO RIP THE ZIPPER COMPLETELY OPEN. SHE FELL OUT OF THE BED A SHORT TIME LATER. THE PT DID NOT SUFFER ANY INJURES. CUSTOMER DID NOT PROVIDE THE PT IDENTIFIER, WEIGHT OR EXACT DAY OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655756 POSEY BED OYS J. T. POSEY CO. 8070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR