BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAMETRIX

    MDR report key: 1628356 · Received November 25, 2009

    Report

    Report Number
    3006891479-2009-00001
    Event Type
    Malfunction
    Date Received
    November 25, 2009
    Date of Event
    October 3, 2009
    Report Date
    November 24, 2009
    Manufacturer
    DIXTAL MEDICAL, INC.
    Product Code
    DQA
    PMA / PMN Number
    K893643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS SUBMITTED WHILE THE MANUFACTURER (DIXTAL MEDICAL INC.) AWAITS THE RESPONSE FROM THE REPORTING FACILITY TO MY REQUEST FOR A COPY OF THE INVESTIGATION FINDINGS (CURRENTLY ONGOING) AS WELL AS MY REQUEST FOR RETURN OF THE DEVICE FOR OUR EVALUATION. THE REPORT CONCERNING THIS MALFUNCTION WAS INITIALLY RECEIVED VIA THE FDA MEDWATCH REPORT # (B)(4) WHICH WAS ACTUALLY RECEIVED BY RESPIRONICS ON OCTOBER 30, 2009 AND SUBSEQUENTLY EMAILED TO ME. THE DEVICE IS REPORTED AS 12 YEARS OLD AND HAS NOT BEEN SERVICED BY DIXTAL SINCE WE ACQUIRED THE PULSE OXIMETRY PRODUCT LINE IN OCTOBER 2007 FROM RESPIRONICS WHO ACQUIRED THE PULSE OXIMETRY PRODUCT LINE FROM (B)(4) IN 2002. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED AS WE MAY RECEIVE RESPONSES TO MY REQUEST FOR ADDITIONAL INFORMATION, REPORTS AND THE RETURN OF THE DEVICE FOR OUR EVALUATION.

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST HAD JUST COMPLETED BREATHING TREATMENT ON A PATIENT AND HEARD A NOISE AND NOTICED SMOKE COMING FROM THE BOTTOM OF THE PULSE OXIMETER LOCATED ON TOP OF A VENTILATOR. NO ADVERSE OUTCOME TO THE PATIENT WAS NOTED. THE PULSE OXIMETER WAS REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAMETRIX PULSE OXIMETER DQA DIXTAL MEDICAL, INC. 515B NA

    Patients

    Seq Age Sex Outcome Treatment
    1