BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER TRANSPORT INCUBATOR

    MDR report key: 8183858 · Received December 20, 2018

    Report

    Report Number
    8183858
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    December 6, 2018
    Report Date
    December 18, 2018
    Manufacturer
    INTERNATIONAL BIOMEDICAL, LTD.
    Product Code
    FPL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NEONATAL TRANSPORT ISOLETTE/OXYGEN DELIVERY-BLENDER DEVICE FAILED DURING (AND PRIOR TO) NEONATAL INTENSIVE CARE UNIT (NICU) TRANSPORT. THIS CAUSED INABILITY TO BRINGING PATIENT BACK ON A LOW FIO2/LOW FLOW NASAL CANNULA, WHICH WAS CURRENT THERAPY ORDERED. HISTORY OF EVENT: BLENDER ALARM NOTED UPON INITIAL ASSESSMENT AROUND 10:00 AM-PRIOR TO LEAVING THE FACILITY ON TRANSPORT. THREE ADDITIONAL RTS EVALUATED THE BLENDER ALARM AND CAME TO THE CONCLUSION THAT BIOMED NEEDED TO BE INVOLVED. BIOMED WAS NOT IMMEDIATELY AVAILABLE, SO ENGINEERING CAME IMMEDIATELY AND THEN WAS ABLE TO INVOLVE BIOMED AFTER FURTHER ASSESSMENT. ONE OF THE AIR REGULATORS WAS FOUND TO HAVE A LARGE LEAK NO MATTER WHAT TROUBLESHOOTING WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024428 VOYAGER TRANSPORT INCUBATOR INCUBATOR, NEONATAL TRANSPORT FPL INTERNATIONAL BIOMEDICAL, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1