BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 4934793 · Received July 21, 2015

    Report

    Report Number
    2021710-2015-01239
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    June 24, 2015
    Report Date
    June 24, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: CHANGED TO VELA VENTILATOR. CHANGED TO VELA PLUS D. INITIAL REPORTER PHONE NUMBER SHOULD HAVE INITIALLY BEEN LEFT BLANK. CHANGED TO OTHER_HEALTH_CARE_PROFESSIONAL. (B)(4). PMA 510(K): CHANGED TO K093094. SHOULD HAVE INITIALLY BEEN UNCHECKED IN INITIAL RESULTS OF INVESTIGATION: RESULTS OF INVESTIGATION: THE MAIN PCBA (PRINTED CIRCUIT BOARD ASSEMBLY) WAS RETURNED TO CAREFUSION¿S FAILURE ANALYSIS LABORATORY. AN INVESTIGATION WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED. THE CAUSE OF THE ISSUE WAS ISOLATED TO TWO FAULTY TRANSDUCERS.

    Additional Manufacturer Narrative · 1

    THE CAREFUSION FAILURE ANALYSIS TECHNICIAN WILL EVALUATE THE ALLEGED FAILED PART IF IT IS RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR IS ALARMING VENT INOP / MOTOR FAULT, AFTER THE VENTILATOR IS POWERED UP IT GIVES 3 BREATHS AND STARTS TO ALARM AND NO VOLUME DELIVERY. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473898 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION VELA PLUS D NA

    Patients

    Seq Age Sex Outcome Treatment
    1