BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 2934667 · Received December 21, 2012

    Report

    Report Number
    2020362-2012-00696
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 26, 2012
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION BUT HAS NOT BEEN REC'D. NOTE: NEVER USE THE BED IF A ZIPPER SLIDER IS BENT OPEN OR DAMAGED AND THE ZIPPER CANNOT BE ZIPPED COMPLETELY CLOSED. REMOVE THE PT FROM THE DAMAGED BED AND EXCHANGE IT FOR A POSEY BED IN GOOD WORKING CONDITION. 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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ZIPPER TEETH ON THE RIGHT SIDE PANEL WILL NOT ALIGN. THE 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
    1 POSEY BED OYS J. T. POSEY CO. 8060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK