BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 3063852 · Received April 3, 2013

    Report

    Report Number
    2020362-2013-00145
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 5, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE REPORTED ISSUE THAT THE ZIPPER IS BROKEN WAS CONFIRMED. EVALUATION REVEALED THAT THE PT ACCESS WINDOW SIDE PANEL SLIDER BODY IS OPEN. NO OTHER VISIBLE DAMGE WAS OBSERVED. NOTE: INSTRUCTION FOR USE STATE: NEVER USE THE BED IF A ZIPPER SLIDER IS BENT OPEN OR DAMAGED AND THE ZIPPER CANNOT BE ZIPPED COMPLETELY CLOSED. NEVER USE THE BED IF A ZIPPER COIL IS KINKED, MISALIGNED, OR HAS GAPS AND DOES NOT CLOSE SECURELY ALONG THE ENTIRE LENGTH. NEVER RIP THE PANELS OPEN, AS THIS WILL DAMAGE THE ZIPPER SLIDER, PREVENTING THE ZIPPER FROM CLOSING SECURELY. BEFORE LEAVING THE PT ALONE, APPLY PRESSURE WITH YOUR HANDS ALONG THE ENTIRE LENGTH OF THE ZIPPER TO MAKE SURE THE PANEL IS SECURELY CLOSED AND THAT THERE ARE NO GAPS OR OPENINGS ALONG THE ENTIRE LENGTH OF EACH ZIPPER. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ZIPPER IS BROKEN ON THE LEFT SIDE PANEL. CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137160 POSEY BED OYS J. T. POSEY CO. 8070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK