BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEL

    MDR report key: 4975724 · Received August 5, 2015

    Report

    Report Number
    2031702-2015-00158
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 6, 2015
    Report Date
    August 5, 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 CAREFUSION SERVICE TECH REPLACED THE PIGTAIL ADAPTER AND THE POWER FLEX CIRCUIT TO CORRECT THE PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD A DAMAGED PIGTAIL. DURING A VISUAL INSPECTION OF THE VENTILATOR, THE CAREFUSION SERVICE TECH FOUND JP4 PIN 2 OF THE POWER FLEX CIRCUIT WAS DAMAGED AND BURNED. THE VENTILATOR PIGTAIL PINS 3 AND 4 WERE BROKEN OFF AND MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516070 REVEL VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC 19260-001

    Patients

    Seq Age Sex Outcome Treatment
    1