BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 5307347 · Received December 17, 2015

    Report

    Report Number
    2021710-2015-02491
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Date of Event
    November 25, 2015
    Report Date
    November 25, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT FAULTY GAS DELIVERY ENGINE (GDE) ASSEMBLY WAS RETURNED TO THE CAREFUSION FAILURE ANALYSIS LAB. THE GDE WAS INSPECTED EXTERNALLY AND NO ANOMALIES WERE NOTED. THE REPORTED PROBLEM OF WATER IN THE GDE WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE GDE INTERNAL COMPONENTS.

    Additional Manufacturer Narrative · 1

    (B)(4) ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE EVALUATED AND INCLUDED IN A FOLLOW-UP REPORT IF REQUIRED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO CAREFUSION THAT THE AVEA VENTILATOR HAD WATER INGRESS IN TO THE GAS DELIVERY ENGINE AND HAS NOW CONTAMINATED IT. NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT WERE RECEIVED BY CAREFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835491 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION AVEA STD COMP CF

    Patients

    Seq Age Sex Outcome Treatment
    1