BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARK 5 NUVO

    MDR report key: 2597655 · Received May 4, 2012

    Report

    Report Number
    1039215-2011-00003
    Event Type
    Malfunction
    Date Received
    May 4, 2012
    Date of Event
    January 16, 2011
    Report Date
    March 1, 2011
    Manufacturer
    NIDEK MEDICAL PRODUCTS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K040892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE EVAL OF THE UNIT, THE RESULTS OF THE CAPACITOR MFRS OBSERVATIONS AND THE CONCLUSIONS OF THE INDEPENDENT TEST LABS THE FAILURE OF THE CAPACITOR WAS A RANDOM FAILURE OF A COMPONENT IN THE UNIT. DUE TO THE SIGNIFICANCE OF THE FAILURE AND THE FACT THAT IT HAS OCCURRED BEFORE, IT WAS DETERMINED THAT A CAPACITOR WITH A HIGHER RATING PROTECTION RATING MAY SERVE TO PREVENT ANY FUTURE FAILURES OF THIS TYPE. THE CAPACITOR SELECTED TO REPLACE THE EPCOS CAPACITOR WAS A CAPACITOR OF THE SAME VOLTAGE AND TEMP RATING BUT WITH A P2 PROTECTION RATING. THE P2 RATING ENSURES THAT IF THE CAPACITOR DOES FAIL IT WILL FAIL TO AN OPEN CONDITION TO PREVENT ANY FAILURES OF THE CASING OF THE CAPACITOR. EVAL REPORT ATTACHED.

    Description of Event or Problem · 1

    AT 4:30 AM A UNIT WITH 9973 HOURS OF USE, WHICH HAD BEEN WITH THE PT FOR SOME MONTHS AND WAS OPERATING IN A NORMAL ENVIRONMENT, IGNITED. IGNITION BELIEVED TO BE CAUSE BY A FAILED CAPACITOR.

    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 Required Intervention