BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARK 5 NUVO LITE

    MDR report key: 18960089 · Received March 22, 2024

    Report

    Report Number
    1039215-2024-00001
    Event Type
    Malfunction
    Date Received
    March 22, 2024
    Date of Event
    March 14, 2024
    Report Date
    March 22, 2024
    Manufacturer
    NIDEK MEDICAL PRODUCTS INC.
    Product Code
    CAW
    PMA / PMN Number
    K123738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE ARE REPORTING THIS OUT OF AN ABUNDANCE OF CAUTION AS THIS IS A DEVICE MODEL NOT SOLD IN THE UNITED STATES, IT WAS A PRIVATE LABEL DEVICE FOR A DISTRIBUTOR IN GERMANY. WE HAVE REQUESTED THE DEVICE BE RETURNED TO OUR FACILITY FOR EVALUATION AND THE DEVICE IS EN ROUTE. IF NECESSARY, A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    INCIDENT DESCRIPTION FROM DISTRIBUTOR: "ACCORDING TO THE PATIENT, THERE WAS A BANG ON (B)(6) 2024 AT AROUND 10.30 PM AND THIS WAS FOLLOWED BY A SHORT CIRCUIT. THE CABLE BURNT OUT/SCORCHED DIRECTLY AT THE END TO THE PLUG AT THE SOCKET. THE PATIENT WAS NOT HARMED AND IS NOT RECEIVING MEDICAL TREATMENT.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1756444 MARK 5 NUVO LITE OXYGEN CONCENTRATOR CAW NIDEK MEDICAL PRODUCTS INC. 925 39139

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown