BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER INFANT TRANSPORT INCUBATOR

    MDR report key: 7534426 · Received May 22, 2018

    Report

    Report Number
    7534426
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    January 18, 2018
    Report Date
    April 17, 2018
    Manufacturer
    INTERNATIONAL BIOMEDICAL, LTD.
    Product Code
    FPL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RISK: WHILE ON NEONATAL INTENSIVE CARE UNIT (NICU) TRANSPORT, THE VENTILATOR IN THE TRANSPORTER SPONTANEOUSLY WENT INTO SYSTEM FAILURE, WHICH CAUSED THE RESPIRATORY THERAPIST TO HAVE TO BAG THE BABY TO KEEP HER VENTILATED FOR THE REMAINDER OF THE TRANSPORT. THE ISOLETTE THEN LOST POWER IN THE AMBULANCE CAUSING THE HEAT TO TURN OFF. THE RESPIRATORY THERAPIST ALSO COULD NOT GET THE MECHANISM THAT HEATS/HUMIDIFIES THE AIR FOR THE VENTILATOR TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374031 VOYAGER INFANT TRANSPORT INCUBATOR INCUBATOR, NEONATAL TRANSPORT FPL INTERNATIONAL BIOMEDICAL, LTD. VOYAGER

    Patients

    Seq Age Sex Outcome Treatment
    1