BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 5224811 · Received November 16, 2015

    Report

    Report Number
    2021710-2015-02205
    Event Type
    Injury
    Date Received
    November 16, 2015
    Date of Event
    October 15, 2015
    Report Date
    October 15, 2015
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS (FA) REPRESENTATIVE (REP) RECEIVED THE ALLEGED FAULTY COMPONENT FOR EVALUATION. THE CAREFUSION FA REP EXAMINED THE FAULTY COMPONENT AND FOUND THAT THE BLUE COOLING GAS TUBING HAD BROKEN OFF. THE CAREFUSION FA REP EXAMINED THE TUBING AND NOTED THAT THE BREAK LOOKED RECENT AND WAS PROBABLY NOT THE CAUSE OF THE OVERHEATING ISSUE. THE CAREFUSION FA REP REPLACED THE BLUE COOLING GAS TUBING AND MEASURED THE DRIVERS COIL RESISTANCE AND FOUND IT TO BE THE CORRECT OHMS. THE CAREFUSION FA REP OPERATED THE UNIT AND NOTED THE DRIVER REMAINED COOL TO THE TOUCH. THE CAREFUSION FA REP WAS UNABLE TO DUPLICATE THE CUSTOMER'S ALLEGED ISSUE. THE CAREFUSION FA REP INDICATED THE DRIVER COULD POTENTIALLY OVERHEAT IF THE COOLING GAS WERE RESTRICTED OR, SOMETHING OTHER THAN THE DRIVER MAY HAVE CAUSED THE BURNING SMELL. DUE TO THE LACK OF DEFINITIVE ROOT CAUSE INFORMATION NO COMPONENT AND SYMPTOM TREND HAS BEEN IDENTIFIED AND THIS IS CONSIDERED TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE USING THE 3100A VENTILATOR ON A PATIENT, THE CUSTOMER NOTICED A BURNING SMELL. THE CUSTOMER WAS UNSURE IF THE OVERHEAT LED INDICATOR WAS ILLUMINATED. THEY EXCHANGED THE VENTILATOR AS A PRECAUTION. THE CUSTOMER REPORTED PATIENT INVOLVEMENT BUT NO ALLEGATION OF PATIENT INJURY/HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756496 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Required Intervention