BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVEA VENTILATOR

    MDR report key: 6126076 · Received November 23, 2016

    Report

    Report Number
    2021710-2016-04916
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    March 24, 2016
    Report Date
    October 13, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICE IS RECEIVED FOR EVALUATION OR ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    A VYAIRE FAILURE ANALYSIS LAB TECHNICIAN WAS ABLE TO VERIFY THE CUSTOMER'S REPORTED ISSUE AND ISOLATE THE REPORTED PROBLEM TO A CORRUPTED BOOTLOADER. DURING BENCH TESTING, THE SCREEN WAS BLACK AND ALL LEDS FROM THE SWITCH MEMBRANE WERE LIT. THE TECHNICIAN CYCLED THE POWER 5 TIMES AND THE UIM BOOTED UP WITH A BLACK SCREEN EVERY TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE, THE VENTILATOR'S TOUCHSCREEN WAS UNRESPONSIVE AND AFTER A POWER CYCLE THE TOUCHSCREEN REMAINED BLANK. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775756 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention