BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION

    MDR report key: 5106144 · Received September 25, 2015

    Report

    Report Number
    2021710-2015-01771
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 4, 2015
    Manufacturer
    CAREFUSION
    Product Code
    BZD
    PMA / PMN Number
    K974303
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION WILL EVALUATE THE ALLEGED FAILED PART IF IT IS RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT CONDENSATION WAS FOUND WHEN THE LP GENERATOR WAS USED FOR PATIENT. AT THAT TIME, PATIENT'S OXYGEN SATURATION WAS DROPPED, AND THE PATIENT WAS INTUBATED. THE NURSE OF THIS FACILITY REPORTED THAT THE LP GENERATORS ARE EASY TO COME DEW CONDENSATE. THEREFORE, THEY HAVE TO REMOVE DEW CONDENSATE FREQUENTLY WITH DISCONNECTION TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635744 CAREFUSION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD CAREFUSION INFANT FLOW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention