BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSEY BED

    MDR report key: 3901701 · Received May 7, 2014

    Report

    Report Number
    2020362-2014-00178
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Report Date
    March 12, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVAL OF THE RETURNED PRODUCT REVEALED THAT THE PT ACCESS PANEL SIDE LEFT, ZIMMER IS MISSING ONE TOOTH ELEMENT. NO OTHER PRODUCT ISSUE WAS FOUND. 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 HAD GAPS AND NOES NOT CLOSE SECURELY ALONG THE ENTIRE LENGTH. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED DAMAGE THAT THE LEFT SIDE PANEL ZIPPER IS BROKEN, IN ADDITION TO THE RETAINING BOX SLIDER. THE ISSUE WAS DISCOVERED WHEN THE PRODUCT WAS REMOVED FROM STORAGE, BUT THE DATE IS UNK. NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276089 PSEY BED OYS J. T. POSEY CO. 8070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA