BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 3131762 · Received May 6, 2013

    Report

    Report Number
    2020362-2013-00204
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Report Date
    April 12, 2013
    Manufacturer
    J. T. POSEY CO.
    Product Code
    OYS
    PMA / PMN Number
    K113355
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION CONFIRMED THE REPORTED ISSUE; THERE IS AN OPEN SLIDER ON THE PATIENT ACCESS OF PANEL SIDE A. NOTE: INSTRUCTIONS FOR USE STATE: TEST THAT ALL ZIPPERS OPEN EASILY AND CLOSE SECURELY ALONG THE ENTIRE LENGTH OF THE ZIPPER. INSPECT ZIPPER COILS FOR ANY KINKS OR MISALIGNMENT. IF ANY ARE IDENTIFIED, ZIP AND UNZIP THE ZIPPER. IF CONDITION CONTINUES, DO NOT USE PRODUCT. DO NOT USE THE POSEY BED IF ZIPPERS HAVE OPEN GAPS THAT DO 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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE TEETH WILL NOT STAY ALIGNED ON THE ZIPPER LOCATED ON THE LEFT SIDE PANEL. CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197764 POSEY BED OYS J. T. POSEY CO. 8060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA