BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEL

    MDR report key: 5142642 · Received October 10, 2015

    Report

    Report Number
    2031702-2015-00239
    Event Type
    Malfunction
    Date Received
    October 10, 2015
    Report Date
    October 9, 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 VENTILATOR WAS RECEIVED WITHOUT THE CUSTOMER OWNED PIGTAIL ADAPTER. A VISUAL INSPECTION OF THE VENTILATOR REVEALED THE POWER FLEX CIRCUIT COMPONENT, JP4 PIN 2 WAS BURNED. THE POWER FLEX CIRCUIT WAS REPLACED TO CORRECT THE PROBLEM THAT WAS FOUND DURING SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD A DAMAGED INPUT PIGTAIL. THE PIGTAIL LEMO CAME OFF AND THE VENTILATOR WAS DAMAGED WHEN THE CUSTOMER ATTEMPTED TO PUT THE PIGTAIL BACK ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673302 REVEL VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC 19260-001

    Patients

    Seq Age Sex Outcome Treatment
    1