BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER TRANSPORT

    MDR report key: 12301117 · Received August 10, 2021

    Report

    Report Number
    12301117
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    August 3, 2021
    Report Date
    August 4, 2021
    Manufacturer
    INTERNATIONAL BIOMEDICAL, LTD.
    Product Code
    FPL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING BIOMEDICAL SERVICE ON THE TRANSPORT ISOLETTE, THE BIOMED ENGINEER FOUND THE ISOLETTE INTERNAL BATTERY CORRODED AND LEAKING ELECTROLYTE THROUGHOUT THE BATTERY BAY. BME FOUND DAMAGED WIRING AND NEGATIVE BATTERY POST COMPLETE CORRODED AND DISCONNECTED. THERE IS EXTENSIVE DAMAGE TO INTERIOR OF BATTERY BAY WHICH WILL REQUIRE RE-WORK AND SURFACE PROTECTION. THERE WAS ALSO EXTENSIVE CORROSION DAMAGE ON ALL GROUNDING POSTS ON THE INTERIOR BATTERY BAY. DEVICE PLACED OUT OF SERVICE TO EXTENSIVE REPAIR WORK. ESTIMATED BATTERY AGE OF 24 MONTHS 12VDC 28AH RATING. MANUFACTURER RESPONSE FOR CRITICAL CARE TRANSPORT ISOLETTE, VOYAGER TRANSPORT (PER SITE REPORTER). AWAITING MANUFACTURER RESPONSE AND ON-SITE VISIT TO DETERMINE ROOT CAUSE OF FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200743 VOYAGER TRANSPORT INCUBATOR, NEONATAL TRANSPORT FPL INTERNATIONAL BIOMEDICAL, LTD. PULSEOX VOYAGER 731-1615

    Patients

    Seq Age Sex Outcome Treatment
    1