BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEL

    MDR report key: 5112506 · Received September 30, 2015

    Report

    Report Number
    2031702-2015-00224
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 29, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    BENCH TESTING REVEALED THAT THE MAIN BOARD COMPONENT U302 HAD BURN MARKS. THE MAIN BOARD WAS REPLACED TO CORRECT THE PROBLEM THAT WAS FOUND DURING SERVICE.

    Description of Event or Problem · 1

    THE VENTILATOR WAS A DEMO UNIT THAT WAS RETURNED. DURING TESTING, THE CAREFUSION SERVICE TECH FOUND THE VENTILATOR HAD A NON-CONFORMANCE WITH THE MEASURED SPO2 DURING THE INITIAL FINAL TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645222 REVEL VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC 19260-001

    Patients

    Seq Age Sex Outcome Treatment
    1