BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 1.5T NEW

    MDR report key: 1912373 · Received November 22, 2010

    Report

    Report Number
    3003768277-2010-00318
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    December 8, 2009
    Report Date
    December 16, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    PMA / PMN Number
    K063559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (METHOD, RESULTS, CONCLUSIONS) - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    THE SERVICE ENGINEER WAS PREPARING THE MFR MAGNET FOR LIQUID HELIUM FILLING. HE OPENED THE FILLING PORT AND PUT HIS GLOVE COVERED HAND OVER THE PORT TO PREVENT LEAKAGE. HE THEN SUFFERED A HELIUM BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHIEVA 1.5T NEW LNH (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) LNH PHILIPS MEDICAL SYSTEMS 781296 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other