BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEL

    MDR report key: 4998587 · Received August 12, 2015

    Report

    Report Number
    2031702-2015-00168
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Report Date
    August 12, 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

    A VISUAL INSPECTION OF THE VENTILATOR REVEALED THAT THE POWER FLEX COMPONENT PIN 4 OF JP4 WAS BURNED. THE POWER FLEX CIRCUIT WAS REPLACED TO CORRECT THE PROBLEM THAT WAS FOUND DURING SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER RETURNED THE VENTILATOR TO THE MANUFACTURER FOR A SCHEDULED PREVENTATIVE MAINTENANCE WITH NO OTHER ISSUES REPORTED. DURING SERVICE OF THE VENTILATOR AT CAREFUSION, A VISUAL INSPECTION REVEALED THAT THE POWER FLEX CIRCUIT WAS BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529685 REVEL VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC 19260-001

    Patients

    Seq Age Sex Outcome Treatment
    1