BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 3221335 · Received July 1, 2013

    Report

    Report Number
    2020362-2013-00302
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 6, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION AND HAS NOT BEEN RECEIVED. NOTE: THIS REPORT IS SUBMITTED BASED ON THE CUSTOMERS REPORTED ISSUE STATEMENT. NOTE: INSTRUCTIONS FOR USE STATES: 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 PATIENT 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. MANUFACTURER REFERENCES FILE NUMBER (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE LEFT SIDE PANEL ZIPPER WILL NOT SECURE CLOSE AND THE TEETH ARE SEPARATING. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297414 POSEY BED OYS J. T. POSEY CO. 8060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK