BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOX T3, NOXTURNAL

    MDR report key: 5247848 · Received November 24, 2015

    Report

    Report Number
    2021710-2015-02297
    Event Type
    Malfunction
    Date Received
    November 24, 2015
    Date of Event
    October 28, 2015
    Report Date
    November 9, 2015
    Manufacturer
    NOX MEDICAL
    Product Code
    MNR
    PMA / PMN Number
    K082113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATING INITIAL MEDWATCH WAS FILED IN ERROR AS DEVICE WAS NOT MANUFACTURED BY (B)(4). THE LEGAL MANUFACTURER OF THE COMPLAINANT DEVICE IS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW UP REPORT. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED BY CAREFUSION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER SLEEP TECHNICIAN PLACED BATTERIES IN THE T3 SLEEP MONITORING DEVICE AND PLACED IT ON HER FINGER TO ENSURE THAT IT WAS WORKING PROPERLY, WHEN SHE DID THIS THE DEVICE DID NOT COME ON, BUT SHE REPORTED SMELLING A "BURNING" SMELL AND THE BACK HOUSING OF THE DEVICE BECAME "VERY WARM." SHE THEN REMOVED THE DEVICE OFF OF HER FINGER AND TOOK OUT THE BATTERIES. WHEN SHE REMOVED THE BATTERIES THEY WERE VERY HOT AND SHE COULD NOT HOLD THEM IN HER HAND SO SHE "DROPPED" THEM ONTO THE COUNTER. THE CUSTOMER REPORTED NO PATIENT INVOLVEMENT OR ALLEGATION OF PATIENT HARM. AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777548 NOX T3, NOXTURNAL VENTILATORY EFFORT RECORDER MNR NOX MEDICAL T3 SLEEP MONITOR 904003664

    Patients

    Seq Age Sex Outcome Treatment
    1