BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE 1.5T

    MDR report key: 2440805 · Received January 30, 2012

    Report

    Report Number
    1525965-2012-00001
    Event Type
    Injury
    Date Received
    January 30, 2012
    Report Date
    January 3, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    LNH
    PMA / PMN Number
    K003853
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMULATED USE TESTING (B)(4); METHOD: TESTING THE DEVICES IN SITUATION THAT MIMIC REAL LIFE SETTINGS BUT DO NOT INVOLVE PATIENTS. RESULTS PENDING COMPLETION OF EVAL (B)(4); RESULTS - FOR USE WHEN THE EVAL IS STILL IN PROGRESS. INCONCLUSIVE-INVESTIGATION IN PROGRESS (B)(4); CONCLUSIONS - THE FIELD SERVICE ENGINEER FOUND NO FAILURE WITH THE MR SYSTEM. THE COIL FAILED ITS PERFORMANCE TEST AND IS BEING RETURNED FOR EVAL. AT THIS TIME, IT IS NOT BELIEVED THAT THIS COIL FAILURE CONTRIBUTED TO THE INCIDENT, HOWEVER FURTHER EVAL WILL BE PERFORMED UPON RECEIPT OF THE COIL.

    Description of Event or Problem · 1

    DURING THE MR SCAN THE OXYGEN MONITOR ALARMED. THE OPERATORS NOTICED THAT THERE WAS A SMALL FIRE INSIDE THE BORE. THE NURSE WENT IMMEDIATELY IN THE EXAM ROOM TO EXTINGUISH THE FIRE WITH THEIR HANDS. THE PT WAS NOT INJURED. THE NURSE SUSTAINED 2ND DEGREE BURNS TO THE RIGHT HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE 1.5T LNH PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 781230

    Patients

    Seq Age Sex Outcome Treatment
    1