BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 4546732 · Received February 19, 2015

    Report

    Report Number
    2021710-2015-00345
    Event Type
    Malfunction
    Date Received
    February 19, 2015
    Date of Event
    January 20, 2015
    Report Date
    January 20, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOREIGN DISTRIBUTOR DID NOT SUBMIT A USER FACILITY/IMPORTER REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION PROVIDED BY THE FOREIGN DISTRIBUTOR. THE FOREIGN DISTRIBUTOR DETERMINED THAT THE CAUSE OF THIS EVENT WAS A FAULTY MAIN BOARD. THE FOREIGN DISTRIBUTOR WAS SHIPPED A REPLACEMENT MAIN BOARD TO REPAIR THE DEVICE AND RETURN IT BACK INTO SERVICE. CAREFUSION ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE FOREIGN DISTRIBUTOR FOR THE RETURN OF THE ALLEGED FAULTY MAIN BOARD FOR EVALUATION. AS OF (B)(6) 2015 THE ALLEGED FAULTY MAIN BOARD HAS NOT BEEN RECEIVED. SHOULD THE ALLEGED FAULTY MAIN BOARD BE RECEIVED AND EVALUATED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CHANGED 510(K) TO K093094. (B)(4). RESULTS OF INVESTIGATION: THE MAIN PCBA (PRINTED CIRCUIT BOARD ASSEMBLY) WAS RETURNED TO CAREFUSION'S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED; HOWEVER, THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE MAIN PCBA WAS FOUND TO BE FUNCTIONING CORRECTLY.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO INFORMATION PROVIDED BY A DISTRIBUTOR IN (B)(6). "OUR DEALER CLAIMS THIS UNIT IS ALARMING "CIRCUIT DISCONNECT". THEY REPLACED THE TURBINE AND THE PROBLEM WAS NOT CORRECTED, THEY CLAIM THE EXHALATION PRESSURE TRANSDUCER FAILED THE CALIBRATION. THE MAIN PCB WAS REPLACED AND THE PROBLEM WAS CORRECTED. THEY CLAIM THIS UNIT IS AN OBF [OUT OF BOX FAILURE]. THIS VENTILATOR WAS NOT ON A PATIENT WHEN THE PROBLEM OCCURRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118858 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION VELA PLUS D NA

    Patients

    Seq Age Sex Outcome Treatment
    1