BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 6210839 · Received December 28, 2016

    Report

    Report Number
    2021710-2016-05118
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    November 29, 2016
    Report Date
    April 5, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICE IS RECEIVED FOR EVALUATION OR ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: CAREFUSION FAILURE ANALYSIS LAB TECHNICIAN COULD NOT BE DUPLICATE THE CUSTOMER'S REPORTED ISSUE DURING BENCH TESTING. THE EXHALATION DIFFERENTIAL PRESSURE TRANSDUCER WAS RESPONSIVE TO PRESSURE INPUT AND THE DIFFERENTIAL VOLTAGE IS WITHIN ACCEPTABLE VALUES. THE SUSPECT COMPONENT PASSED ALL TESTING AND MET ALL CAREFUSION MANUFACTURER SPECIFICATIONS. EXAMINATION OF THE 4 RECORDED TRANSDUCER FAULTS SHOW THAT 2 OCCURRED WITH A CIRCUIT DISCONNECT ALARM AND THE REMAINING OCCURRED AT POWER-UP. THIS INDICATES THAT TRANSDUCER FAULT WAS RELATED TO A PROBLEM WITH THE PATIENT CIRCUIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE THE VENTILATOR ALARMED TRANSDUCER FAULT. THERE WAS NO HARM TO THE PATIENT AS THEY WERE SWITCHED TO AN ALTERNATE VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858038 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention