BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 6090113 · Received November 9, 2016

    Report

    Report Number
    2021710-2016-04814
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 10, 2016
    Report Date
    November 9, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION COMPLAINT NUMBER: (B)(4). IN THE EVENT THE DEVICE IS RECEIVED FOR EVALUATION OR ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR'S HEATER ASSEMBLY FAILED AND OVERHEATED BURNING THE EXHALATION CORNER PLASTIC. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739537 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1