BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS MOBILE WORKSTATION

    MDR report key: 2002605 · Received February 8, 2011

    Report

    Report Number
    9611174-2011-00001
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Report Date
    June 11, 2009
    Manufacturer
    KEYMED LTD.
    Product Code
    FET
    Removal / Correction Number
    2429304-05/13/09-010-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO (B)(4) FOR EVALUATION. THE USER FACILITY WAS PROVIDED WITH A REPLACEMENT DEVICE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REGISTRATION NUMBER FOR THIS CORRECTION IS (B)(4). THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    DURING AN INSPECTION OF THE WORKSTATION, THE FUSE OF THE WORKSTATION WAS FOUND CHARRED. THERE WAS NO USER OR PT INJURY ASSOCIATED WITH THIS EVENT. THE WORKSTATION WAS REPORTEDLY REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS MOBILE WORKSTATION MOBILE WORKSTATION FET KEYMED LTD. WM-DP1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1