BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEL

    MDR report key: 5033294 · Received August 26, 2015

    Report

    Report Number
    2031702-2015-00187
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Report Date
    August 26, 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 TECHNICIAN WAS ABLE TO VERIFY THE REPORTED PROBLEM. THE PIGTAIL CABLE HAD BROKEN OFF FROM THE PIGTAIL ELBOW CONNECTOR. FURTHER VISUAL INSPECTION REVEALED THAT THE POWER FLEX CIRCUIT LEMO CONNECTOR, JP4 PIN# 2, WAS BURNED. THE PIGTAIL WAS REPLACED TO CORRECT THE REPORTED PROBLEM. THE POWER FLEX CIRCUIT WAS REPLACED TO CORRECT THE PROBLEM THAT WAS FOUND DURING SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE VENTILATOR'S PIGTAIL ADAPTER WAS DAMAGED WITH EXPOSED WIRES. DURING SERVICE, THE CAREFUSION SERVICE TECH FOUND THE POWER FLEX CIRCUIT LEMO CONNECTOR WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566321 REVEL VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC 19260-001

    Patients

    Seq Age Sex Outcome Treatment
    1