BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARK 5 NUVO

    MDR report key: 2654494 · Received June 29, 2012

    Report

    Report Number
    1039215-2012-00002
    Event Type
    Malfunction
    Date Received
    June 29, 2012
    Date of Event
    February 15, 2011
    Report Date
    June 28, 2012
    Manufacturer
    NIDEK MEDICAL PRODUCTS, INC.
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTOGRAPH INDICATES FAILURE OF CAPACITOR BY THE PROXIMITY OF THE DAMAGE TO THE LOCATION OF THE CAPACITOR. CUSTOMER ALSO INDICATED THAT THE CAPACITOR HAD FAILED. CUSTOMER MISIDENTIFIED THE MODEL NUMBER AS 925 WHEN IT'S ACTUALLY 905.

    Description of Event or Problem · 1

    FAULTY CAPACITOR CAUSED FIRE, ONLY DEVICE DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARK 5 NUVO GENERATOR, OXYGEN PORTABLE CAW NIDEK MEDICAL PRODUCTS, INC. 905

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR