BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEL

    MDR report key: 5021724 · Received August 21, 2015

    Report

    Report Number
    2031702-2015-00182
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Report Date
    August 21, 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'S PIGTAIL ADAPTER REVEALED PIN 4 WAS BURNED. THE PIGTAIL ADAPTER WAS REPLACED TO CORRECT THE PROBLEM THAT WAS IDENTIFIED DURING SERVICE OF THE VENTILATOR. THE POWER FLEX CIRCUIT WAS REPLACED AS A PRECAUTION.

    Description of Event or Problem · 1

    THE VENTILATOR WAS SENT TO CAREFUSION SERVICE FOR A 15K PM WITH NO OTHER PROBLEMS IDENTIFIED BY THE CUSTOMER. A VISUAL INSPECTION OF THE VENTILATOR DURING SERVICE REVEALED THAT THE PIGTAIL ADAPTER WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555993 REVEL VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC 19260-001

    Patients

    Seq Age Sex Outcome Treatment
    1