BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEL

    MDR report key: 4957444 · Received July 31, 2015

    Report

    Report Number
    2031702-2015-00156
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    June 18, 2015
    Report Date
    July 31, 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

    THE POWER FLEX CIRCUIT WAS REPLACED TO CORRECT THE PROBLEM THAT WAS FOUND DURING SERVICE. DURING THE INITIAL FINAL TEST, THE VENTILATOR ALSO HAD A NON-CONFORMANCE WITH THE MEASURED O2 PRESSURE PERFORMANCE TEST. THE O2 MODULE WAS REPLACED.THIS MDR IS BEING FILED BEYOND THE 30 DAY FILING TIME FRAME.

    Description of Event or Problem · 1

    THE CUSTOMER HAD SENT THE VENTILATOR TO CAREFUSION FOR A 15K PREVENTATIVE MAINTENANCE. DURING A VISUAL INSPECTION, THE CAREFUSION SERVICE TECH FOUND JP4 PIN 2 OF THE POWER FLEX CIRCUIT WAS DAMAGED AND BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501410 REVEL VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC 19260-001

    Patients

    Seq Age Sex Outcome Treatment
    1