BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 6243092 · Received January 11, 2017

    Report

    Report Number
    2021710-2017-05200
    Event Type
    Injury
    Date Received
    January 11, 2017
    Date of Event
    December 12, 2016
    Report Date
    April 24, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: A CAREFUSION CERTIFIED FIELD SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED COMPLAINT (UNIT REPORTED TO HAVE VENTILATOR INOPERABLE ALARM). THE REPORTED ISSUE WAS RESOLVED BY REPLACING THE MAIN PRINTED CIRCUIT BOARD. THE UNIT WAS TESTED AFTER THE REPLACEMENT AND THE DEVICE IS NOW WORKING TO MANUFACTURER SPECIFICATIONS. AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT COMPONENT FOR EVALUATION. IF THE COMPONENT IS RETURNED THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER AN INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE SUSPECT COMPONENT (PRINTED CIRCUIT BOARD) WAS RETURNED TO CAREFUSION'S FAILURE ANALYSIS LABORATORY. THE INVESTIGATOR WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. DURING INVESTIGATION, IT WAS DETERMINED THAT ALL OF THE TRANSDUCERS WERE RESPONDING TO PRESSURE INPUT APPROPRIATELY AND THE OUTPUT DIFFERENTIAL VOLTAGE (ODV) WAS WITHIN THE MANUFACTURER SPECIFICATION. NO FAILURES WERE DETECTED BUT IT WAS CONFIRMED IN THE EVENT LOGS THAT A TRANSDUCER FAULT HAD OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT DISPLAYED VENTILATOR INOPERABLE ALARM UNEXPECTEDLY WHILE BEING USED ON THE PATIENT. THE REPORTED VENTILATOR WAS IMMEDIATELY REPLACED BY A BACKUP VENTILATOR. THE CUSTOMER REPORTED NO HARM OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24566 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC VELA VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention