BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 6329336 · Received February 14, 2017

    Report

    Report Number
    2021710-2017-05401
    Event Type
    Injury
    Date Received
    February 14, 2017
    Date of Event
    January 14, 2017
    Report Date
    March 22, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT COMPONENT WAS RETURNED TO CAREFUSION'S FAILURE ANALYSIS LABORATORY. THE INVESTIGATOR WAS ABLE TO DUPLICATE THE REPORTED ISSUE. DURING INVESTIGATION, IT WAS DETERMINED THAT THE TURBINE DIFFERENTIAL PRESSURE TRANSDUCER WAS RESPONDING TO PRESSURE INPUT, HOWEVER, THE OUTPUT DIFFERENTIAL VOLTAGE (ODV) WAS OUT OF MANUFACTURER SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). FIELD SERVICE REPRESENTATIVE (FSR) WENT ONSITE TO EVALUATE THE DEVICE. THE FSR CONFIRMED THAT THE DEVICE DISPLAYED VENTILATOR INOPERABLE ALARM. THE REPORTED ISSUE WAS RESOLVED BY REPLACING THE MAIN PRINTED CIRCUIT BOARD (PCB). THE DEVICE WAS RETURNED TO THE CUSTOMER OPERATING TO SERVICE SPECIFICATIONS. THE SUSPECT MAIN PCB HAS BEEN RECEIVED BY CAREFUSION AND IT IS IN PROCESS TO BE EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER AN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SUSPECT VELA VENTILATOR DISPLAYED VENTILATOR INOPERABLE ALARM WITH MANY OTHER ALARMS WHILE IN USE WITH A PATIENT. THE PATIENT WAS SWITCHED TO ANOTHER VENTILATOR BY THE RESPIRATORY THERAPIST AND THERE WAS NO HARM TO ANY PATIENT OR CLINICIAN IN ASSOCIATION WITH THE REPORTED COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111900 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC VELA VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention