BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOX T3, NOXTURNAL

    MDR report key: 5746831 · Received June 23, 2016

    Report

    Report Number
    2021710-2016-03954
    Event Type
    Malfunction
    Date Received
    June 23, 2016
    Date of Event
    June 2, 2016
    Report Date
    June 2, 2016
    Manufacturer
    NOX MEDICAL
    Product Code
    MNR
    PMA / PMN Number
    K082113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION FILE IDENTIFICATION: (B)(4). IMPORTER REPORT NUMBER: 2021710-2016-00003 (B)(4). CAREFUSION IS THE IMPORTER OF RECORD FOR THIS DEVICE. THE LEGAL MANUFACTURER (NOX MEDICAL) HAS BEEN NOTIFIED OF THE REPORTED EVENT. ANY FURTHER REPORTS WILL COME FROM THE LEGAL MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE TROUBLESHOOTING A DIFFERENT ISSUE WITH CAREFUSION TECHNICAL SUPPORT THE DEVICE BECAME VERY HOT, SHUTDOWN, AND WOULD NOT POWER ON AGAIN. THE CUSTOMER REPORTED THAT THEY HAD JUST CHANGED THE BATTERIES IN THE DEVICE APPROXIMATELY 30 MINUTES PRIOR TO THE OCCURRENCE OF THE REPORTED INCIDENT. THE CUSTOMER STATED THAT THEY COULD SMELL SOMETHING THAT SMELLED LIKE BURNT PLASTIC HOWEVER THE CUSTOMER DID NOT NOTE ANY AREA ON THE DEVICE THAT APPEARED TO BE BURNED. THE CUSTOMER THEN STATED THAT SHE REMOVED THE BATTERIES AND SAT THE DEVICE ASIDE UNTIL IT COOLED DOWN. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT AND NO REPORT OF SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398556 NOX T3, NOXTURNAL VENTILATORY EFFORT RECORDER MNR NOX MEDICAL T3 SLEEP MONITOR

    Patients

    Seq Age Sex Outcome Treatment
    1