BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARK 5 NUVO

    MDR report key: 1394723 · Received April 1, 2009

    Report

    Report Number
    1039215-2009-00002
    Event Type
    Malfunction
    Date Received
    April 1, 2009
    Report Date
    March 31, 2009
    Manufacturer
    NIDEK MEDICAL PRODUCTS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K032509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPACITOR COMPONENT SHORTED CAUSING BURNT SMELL. MANUFACTURER RETURNED CAPACITOR TO PART SUPPLIER FOR EVAL, BUT PART WAS LOST AT SUPPLIER. NO DAMAGE TO DEVICE WAS NOTED. CAPACITOR WAS REPLACED AND DEVICE WAS WITHIN SPECIFICATIONS. INITIAL REPORTER CONTACTED ON 03/16/2009 TO OBTAIN MISSING INFO REGARDING MALFUNCTION. INITIAL RPTR STATED "NO INCIDENT. NO COMPLAINT FROM PT."

    Description of Event or Problem · 1

    "ONE UNITS OF CAPACITOR IS BURN DURING PT IN USE. SHE COMPLAINT SMOKE COMING OUT AND SMELL. WE CHANGE IT IMMEDIATELY. CASE CLOSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARK 5 NUVO GENERATOR, OXYGEN, PORTABLE - CAW CAW NIDEK MEDICAL PRODUCTS, INC. MARK5 NUVO/M5C5

    Patients

    Seq Age Sex Outcome Treatment
    1