BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARK 5 NUVO LITE

    MDR report key: 14845148 · Received June 28, 2022

    Report

    Report Number
    1039215-2022-00001
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    June 13, 2022
    Report Date
    June 14, 2022
    Manufacturer
    NIDEK MEDICAL PRODUCTS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K082566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON PICTURES PROVIDED AND HISTORICAL DATA, IT WAS DETERMINED THAT THE CAPACITOR FAILED AS INTENDED. ALSO DETERMINED THAT WHILE THE DEVICE HAD BEEN A PART OF A CLOSED FIELD CORRECTION, THE CORRECTION HAD BEEN IMPLEMENTED AND THEREFORE THE CAPACITOR INVOLVED MEETS ALL CURRENT SAFETY STANDARDS. PROVIDED INFORMATION TO DISTRIBUTOR REGARDING CAPACITOR SPECIFICATIONS THAT INCLUDED SAFETY FEATURES AND TYPICAL FAILURE MODES. THIS INFORMATION IS BEING REPORTED TO THE FDA OUT OF AN ABUNDANCE OF CAUTION DUE TO IT INVOLVING AN ELECTRICAL COMPONENT THAT FAILED AS DESIGNED.

    Description of Event or Problem · 0

    CUSTOMER RECEIVED DEVICE FOR SERVICING AND UPON INSPECTION FOUND THE CAPACITOR HAD FAILED. CUSTOMER THEN NOTIFIED NIDEK OF THE FAILURE, SENT PICTURES OF CAPACITOR AND REQUESTED SAFETY AND RISK INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029804 MARK 5 NUVO LITE OXYGEN CONCENTRATOR CAW NIDEK MEDICAL PRODUCTS, INC. 925 13700

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown