BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA

    MDR report key: 9069712 · Received September 16, 2019

    Report

    Report Number
    9069712
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Date of Event
    August 22, 2019
    Report Date
    September 3, 2019
    Manufacturer
    GE MEDICAL SYSTEMS, INC.
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RISK, RDE--- BATTERY PACK MALFUNCTIONED CAUSING SMOKE TO FILL THE AREA. THE BATTERY PACK CAUGHT FIRE SO THAT IS BURNED THROUGH THE METAL HOUSING. THE UNIT WAS MOVED OUTSIDE UNTIL THE BATTERY STOPPED ARCING. THEN THE BATTERY WAS REPLACED TO MOVE THE PORTABLE BACK INSIDE FOR FOLLOW UP TESTING. WORK ORDERS FOR SERVICE ON THIS UNIT. THE OEM HAS BEEN CALLED IN TO VALIDATE UNIT FUNCTION AFTER THE INCIDENT.

    Description of Event or Problem · 1

    RISK,RDE--- BATTERY PACK MALFUNCTIONED CAUSING SMOKE TO FILL THE AREA. THE BATTERY PACK CAUGHT FIRE SO THAT IS BURNED THROUGH THE METAL HOUSING. THE UNIT WAS MOVED OUTSIDE UNTIL THE BATTERY STOPPED ARCING. THEN THE BATTERY WAS REPLACED TO MOVE THE PORTABLE BACK INSIDE FOR FOLLOW UP TESTING. WORK ORDERS FOR SERVICE ON THIS UNIT. THE OEM HAS BEEN CALLED IN TO VALIDATE UNIT FUNCTION AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865952 OPTIMA SYSTEM, X-RAY, MOBILE IZL GE MEDICAL SYSTEMS, INC. XR220AMX

    Patients

    Seq Age Sex Outcome Treatment
    1