BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 4927875 · Received July 17, 2015

    Report

    Report Number
    2021710-2015-01232
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 19, 2015
    Report Date
    June 19, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Removal / Correction Number
    Z-1609-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A CAREFUSION FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE USER FACILITY. THE FIELD SERVICE REPRESENTATIVE EVALUATED THE DEVICE VERIFIED THE REPORTED ISSUE AND DETERMINED THAT THE MOST LIKELY ROOT CAUSE WAS THAT THE INSPIRATORY FLOW SENSOR IN THE GAS DELIVERY ENGINE (GDE) WAS MALFUNCTIONING. AT PRESENT THERE ARE NO REPLACEMENT PARTS AVAILABLE. ONCE AVAILABLE, A REPLACEMENT GAS DELIVERY ENGINE (GDE) WILL BE PROVIDED TO THE USER FACILITY TO REPAIR THE DEVICE AND RETURN IT TO SERVICE.

    Additional Manufacturer Narrative · 1

    CORRECTION: CHANGED TO AVEA VENTILATOR. CHANGED TO HEALTH PROFESSIONAL. CHANGED TO K103211. ADDITIONAL INFORMATION: THE REPORTED ISSUE OF THE SUSPECT DEVICE WAS RESOLVED BY PERFORMING REMEDIATION OF THE DEVICE UNDER FIELD CORRECTIVE ACTION. THE DEVICE HAS BEEN TESTED AND IS WORKING TO SERVICE SPECIFICATIONS. NO FURTHER INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE USER FACILITY BIOMED REPORTED THAT WHILE PERFORMING THE EXTENDED SYSTEMS TEST (EST) ON THE DEVICE. THE DEVICE FAILED AND ALARMED "CIRCUIT OCCLUSION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465227 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE/CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA