BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 6216500 · Received December 30, 2016

    Report

    Report Number
    2021710-2016-05156
    Event Type
    Injury
    Date Received
    December 30, 2016
    Date of Event
    October 12, 2016
    Report Date
    December 30, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE REPRESENTATIVE (FSR) WENT ON-SITE TO EVALUATE THE SUSPECT DEVICE. THE FSR DETERMINED THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). AFTER REPLACING THE MAIN PCBA, THE ISSUE WAS RESOLVED. THE FSR PERFORMED THE USER VERIFICATION TEST AND OPERATIONAL VERIFICATION PROCEDURE, ACCORDING TO MANUFACTURER SPECIFICATIONS. THE CUSTOMER REPORTED THE MAIN PCBA HAS BEEN DISPOSED OF, THEREFORE NO FURTHER EVALUATION CAN BE PERFORMED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FINDING A VENTILATOR IN THE BACK ROOM WITH A PAPER ON IT THAT SAYS THE VENTILATOR WAS ON A PATIENT AND STARTED ALARMING DEFAULT. THE CUSTOMER REPORTED THERE IS NO PATIENT CONSEQUENCE ASSOCIATED WITH THE EVENT. THE FIELD SERVICE REPRESENTATIVE (FSR) WENT ON-SITE TO EVALUATE THE SUSPECT DEVICE AND REPORTED THE UNIT WAS ALARMING TRANSDUCER FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865024 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention