BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARK 5 NUVO

    MDR report key: 10885720 · Received November 23, 2020

    Report

    Report Number
    1039215-2020-00001
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Date of Event
    October 25, 2020
    Report Date
    November 18, 2020
    Manufacturer
    NIDEK MEDICAL PRODUCTS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K040892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN OXYGEN CONCENTRATOR HAD EVIDENCE OF THERMAL DAMAGE. THE SERIAL NUMBER OF THE DEVICE WAS INCLUDED IN A PREVIOUSLY CLOSED FIELD CORRECTION. RECORDS SHOW SENDING REPLACEMENT PART TO DISTRIBUTOR, HOWEVER THERE IS NO CONFIRMATION THAT THE PART WAS ACTUALLY REPLACED. BASED ON INFORMATION PROVIDED, THE EVENT WAS LIKELY CAUSED BY THE DEFECTIVE COMPONENT. NO INDICATION OF HARM TO THE PATIENT, NOR PROPERTY DAMAGE. THIS REPORT IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION, AS THIS ISSUE HAS ALREADY BEEN INVESTIGATED.

    Description of Event or Problem · 1

    DISTRIBUTOR IN (B)(4) RECEIVED NOTIFICATION OF A DEVICE WITH THERMAL DAMAGE. DEVICE WAS PICKED UP BY DISTRIBUTOR, PHOTOGRAPHED AND THEN DISCARDED. THERE IS NO MENTION OF HARM TO PATIENT OR THEIR HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347720 MARK 5 NUVO OXYGEN CONCENTRATOR CAW NIDEK MEDICAL PRODUCTS, INC. 905

    Patients

    Seq Age Sex Outcome Treatment
    1