BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRBORNE TRANSPORT INCUBATORS A 750I

    MDR report key: 5549836 · Received April 6, 2016

    Report

    Report Number
    5549836
    Event Type
    Malfunction
    Date Received
    April 6, 2016
    Date of Event
    March 25, 2016
    Report Date
    March 30, 2016
    Manufacturer
    INTERNATIONAL BIOMEDICAL LTD
    Product Code
    FPL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ORANGE WIRE RUNNING FROM THE BRIDGE RECTIFIER TO THE TRANSFORMER BURNT UP. ALL THE WIRES AND INTERNAL COMPONENTS ARE ORIGINAL FROM THE FACTORY. THIS CAUSED A POWER FAILURE AND THE ISOLETTE WAS UNABLE TO FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206652 AIRBORNE TRANSPORT INCUBATORS A 750I INCUBATOR, NEONATAL TRANSPORT FPL INTERNATIONAL BIOMEDICAL LTD A 750I

    Patients

    Seq Age Sex Outcome Treatment
    1