BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 7138295 · Received December 21, 2017

    Report

    Report Number
    2021710-2017-07176
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    December 11, 2017
    Report Date
    January 30, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. THE CUSTOMER REPORTED THE SUSPECT DEVICE WILL BE REWORKED BY THEIR FACILITY BIOMED WITH A REPLACEMENT DISPLAY COMPONENT. AT THIS TIME, VYAIRE MEDICAL HAS NOT RECEIVED THE SUSPECT DEVICE COMPONENT FOR EVALUATION. IN THE EVENT THAT THE DEVICE IS RECEIVED FOR EVALUATION OR ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE VYAIRE FAILURE ANALYSIS (FA) LABORATORY RECEIVED THE SUSPECT USER INTERFACE MODULE (UIM) FOR INVESTIGATION. THE FA LABORATORY CYCLED ON THE UIM AND IT COMPLETED THE BOOT UP PROCESS NORMALLY. A TWO HOUR RUNTIME ROUTINE WAS PERFORMED WITH NO ANOMALIES. THE FA LABORATORY ALSO PERFORMED THE TOUCHSCREEN CALIBRATION AND PASSED. A VISUAL INSPECTION OF THE INTERNAL COMPONENTS WAS PERFORMED WITH NO ANOMALIES. AT THIS TIME, THE FA LABORATORY COULD NOT DUPLICATE THE CUSTOMER EVENT THEREFORE, NO ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNRESPONSIVE TOUCHSCREEN DISPLAY ON THIS VENTILATOR DEVICE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918012 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1