BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEL

    MDR report key: 5102469 · Received September 24, 2015

    Report

    Report Number
    2031702-2015-00221
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Report Date
    September 24, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. AFTER THE VENTILATOR WAS POWERED ON IN SERVICE, IT HAD A HARDWARE FAULT ALARM CONDITION. THE HYBRID BOARD PC10 ULTRA CAPACITOR HAD MALFUNCTIONED. THE HYBRID BOARD WAS REPLACED TO CORRECT THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    THE VENTILATOR WAS ORIGINALLY BEING RETURNED FOR A SCHEDULED PREVENTATIVE MAINTENANCE. THE VENTILATOR WAS RECEIVED WITH A NOTE STATING THAT THE VENTILATOR HAD FAILED DURING TRANSPORT (HW FAULT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630700 REVEL VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC 19260-001

    Patients

    Seq Age Sex Outcome Treatment
    1