BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 7215990 · Received January 24, 2018

    Report

    Report Number
    2021710-2018-07344
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Date of Event
    September 21, 2017
    Report Date
    April 24, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED THE SUSPECT COMPONENT, A MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA), TO VYAIRE MEDICAL, INC. AND IT IS CURRENTLY PENDING FAILURE ANALYSIS. ONCE THE FINAL EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    RESULT OF INVESTIGATIONS: THE VYAIRE FAILURE ANALYSIS LAB RECEIVED THE SUSPECT COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS CONFIRMED AND DUPLICATED IN THE LABORATORY SETTING. THE ROOT CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE A FAILED PRESSURE TRANSDUCER (PT802), WHICH WAS UNABLE TO BE CALIBRATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR VELA VENTILATOR ALARMED "TRANSDUCER FAULT". THE CUSTOMER REQUESTED A NEW MAIN PRINTED CIRCUIT BOARD ASSEMBLY TO RESOLVE THE ISSUE. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60118 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1