BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 6216512 · Received December 30, 2016

    Report

    Report Number
    2021710-2016-05154
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    December 2, 2016
    Report Date
    April 10, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION FILE IDENTIFICATION: (B)(4). (B)(4). A CAREFUSION FIELD SERVICE REPRESENTATIVE WENT ONSITE AND THE REPORTED ISSUE WAS RESOLVED BY REPLACING THE MAIN BOARD. THE SUSPECT MAIN BOARD HASN'T BEEN RECEIVED AT THIS TIME BY CAREFUSION. IF THE DEVICE IS RETURNED THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER AN INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: THE SUSPECT COMPONENT (PRINTED CIRCUIT BOARD) 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 (PT801) WAS RESPONDING TO PRESSURE INPUT, HOWEVER, THE OUTPUT DIFFERENTIAL VOLTAGE (ODV) WAS OUT OF MANUFACTURER SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR VELA VENTILATOR DISPLAYED A TRANSDUCER FAULT ALARM. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866034 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC VELA VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1