BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYCON MOBILE

    MDR report key: 5536781 · Received March 30, 2016

    Report

    Report Number
    2021710-2016-03409
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    CAREFUSION, INC
    Product Code
    BZC
    PMA / PMN Number
    K023120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO A RETROSPECTIVE COMPLAINT REVIEW PERFORMED BY CAREFUSION. THE CAREFUSION IDENTIFICATION FILE IS (B)(4). THE DEVICE WAS EVALUATED AT THE CUSTOMER'S FACILITY BY A CAREFUSION FIELD SERVICE ENGINEER (FSE). HE WAS UNABLE TO DUPLICATE THE REPORTED EVENT. AS A CORRECTION, THE FSE INSTALLED THE HOTFIX SOFTWARE AND DID A SYSTEM CALIBRATION. CAREFUSION CONTINUES TO TRACK AND TREND ANY INCIDENT RELATED TO THIS ISSUE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE EMERGENCY STOP FUNCTION ON THEIR NORDICTRACK X9I TREADMILL CAUSES THE (B)(4) SOFTWARE TO SHUT OFF. WHEN THE SOFTWARE SHUTS OFF SO DOES THE ECG AND BREATH BY BREATH MONITORING. THERE WAS NO KNOWN PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE EMERGENCY STOP FUNCTION ON THEIR NORDICTRACK X9I TREADMILL CAUSES THE JLAB SOFTWARE TO SHUT OFF. WHEN THE SOFTWARE SHUTS OFF SO DOES THE ECG AND BREATH BY BREATH MONITORING. THE CUSTOMER DID NOT CLARIFY IF THERE WAS PATIENT INVOLVEMENT OR NOT, IT IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192560 OXYCON MOBILE CALCULATOR, PULMONARY FUNCTION DATA BZC CAREFUSION, INC OXYCON MOBILE

    Patients

    Seq Age Sex Outcome Treatment
    1