BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 5115313 · Received September 30, 2015

    Report

    Report Number
    2021710-2015-01847
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    September 3, 2015
    Report Date
    September 10, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: THE SUSPECT OXYGEN (O2) SENSOR ASSEMBLY WAS RECEIVED FROM FURTHER ANALYSIS BY THE VENDOR, ANALYTICAL INDUSTRIES (AI) INC. PERFORMANCE TESTS FROM THE VENDOR SHOW THE O2 SENSOR PASSED TESTING. THE FAILURE ANALYSIS REPORT PERFORMED BY CAREFUSION WAS INVESTIGATED AND FOUND THE BLENDER ASSEMBLY ASSOCIATED WITH TESTING WAS AT FAULT. THE BLENDER ASSEMBLY WAS REPLACED WITH A KNOWN GOOD BLENDER ASSEMBLY AND THE FIO2 PERFORMANCE TEST WAS REPORTED. THE O2 SENSOR PASSED WITH NO ANOMALIES CONFIRMING THE REPORT RECEIVED FROM AI. DUE TO THE SUSPECT COMPONENT BEING WITHIN SPECIFICATIONS, NO FURTHER INVESTIGATION WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DISTRIBUTOR IN (B)(4) DETERMINED THAT THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS THAT THE DEVICE¿S O2 SENSOR WAS MALFUNCTIONING. THE DISTRIBUTOR IN (B)(4) WAS SHIPPED A REPLACEMENT O2 SENSOR TO REPAIR THE DEVICE AND RETURN IT TO SERVICE. CAREFUSION ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE DISTRIBUTOR IN (B)(4) FOR THE RETURN OF THE ALLEGED FAULTY O2 SENSOR FOR EVALUATION. THE ALLEGED FAULTY O2 SENSOR HAS BEEN RECEIVED, ROUTED TO THE CAREFUSION FAILURE ANALYSIS LAB AND STAGED FOR EVALUATION. ONCE THE EVALUATION OF THE O2 SENSOR IS COMPLETE, CAREFUSION WILL SUBMIT A FOLLOW-UP MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS (FA) LAB RECEIVED A VELA O2 SENSOR. THE VELA O2 SENSOR WAS INSTALLED INTO A KNOWN GOOD UNIT AND PERFORM AMBIENT AND 100% PASS. PERFORM FIO2 PERFORMANCE AND TESTING FAILED DURING 30%, 60%, 90% READINGS WITH CHECK O2 CAL AND READING OUT OF RANGE. THE CUSTOMER ISSUE WAS DUPLICATED. THE SENSOR WILL BE SENT BACK TO ANALYTICAL INDUSTRIES INC. FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    THE DISTRIBUTOR IN (B)(4) REPORTED THAT WHILE IN USE ON A PATIENT THE DEVICE ALARMED ¿O2 SENSOR FAILURE¿. THE PATIENT WAS REMOVED FROM THE DEVICE AND PLACED ON ANOTHER DEVICE. THERE WAS NO REPORT OF HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644571 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION VELA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention