BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARK 5 NUVO LITE

    MDR report key: 3026150 · Received March 22, 2013

    Report

    Report Number
    1039215-2013-00001
    Event Type
    Death
    Date Received
    March 22, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 22, 2013
    Manufacturer
    NIDEK MEDICAL PRODUCTS, INC.
    Product Code
    CAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT CONCENTRATOR HAD BEEN RETURNED FOR SERVICE (B)(4) 2011. TIMING BOARD AND MODULE WERE REPLACED AT 3829 HOURS. DEVICE SHIPPED BACK TO HOSPITAL ON (B)(4) 2011. PRELIMINARY EVALUATION: DEVICE WAS RECEIVED BACK FROM RCH ON (B)(4) 2013 WITH 6362.7 HOURS. CABINET WAS IN GOOD CONDITION EXCEPT SHOWED NORMAL DIRT, SCRATCHES AND ABRASIONS. INLET AIR FILTER WAS DETACHED LYING IN THE CARTON AND THE CONNECTOR WERE MISSING. FLOW CONTROL WAS SET AT 2 1/MIN. TAPE WAS WRAPPED AROUND THE OXYGEN OUTLET FITTING. THERE WAS NO HUMIDIFIER ATTACHED. UNIT WAS TURNED ON AT 11:10 A.M. AND EXHIBITED A LOUD NOISE TYPICAL OF A FAILED COMPRESSOR BEARING. OXYGEN CONCENTRATION REACHED 93.2/93.8 PERCENT WITHIN SEVERAL MINUTES OF OPERATION. THE ACTUAL FLOW RATE WAS MEASURED AT 2 1/MIN. THE LOUD BEARING NOISE ENDED AT 11:20 AS THE COMPRESSOR SEIZED. THE RED LIGHT LIGHTED AND THE ALARM SOUNDED WITHIN A FEW SECONDS. OXYGEN PRODUCT FLOW DIMINISHED AND STOPPED WITHIN A SHORT TIME INTERVAL. OXYGEN CONCENTRATION CONTINUED AT 93+ PERCENT UNTIL FLOW STOPPED.

    Description of Event or Problem · 1

    "A PATIENT WAS SENT TO THE HOSPITAL AND THE FAMILY IS BLAMING THE CONCENTRATOR FOR NOT PRODUCING THE APPROPRIATE AIRFLOW." PATIENT: (B)(6), UNDER HOSPICE CARE, DIES IN THE FACILITY ON (B)(6) 2013. HE WAS USING OR HAD USED THE CONCENTRATOR INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119784 MARK 5 NUVO LITE GENERATOR, OXYGEN PORTABLE CAW NIDEK MEDICAL PRODUCTS, INC. 520

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death