BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAGNETOM SPECTRA

    MDR report key: 5603586 · Received April 25, 2016

    Report

    Report Number
    2240869-2016-02327
    Event Type
    Death
    Date Received
    April 25, 2016
    Date of Event
    April 3, 2016
    Report Date
    April 22, 2016
    Manufacturer
    SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
    Product Code
    LNH
    PMA / PMN Number
    K153447
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENGINEER RECEIVED IMMEDIATE MEDICAL TREATMENT AND NO SURGICAL PROCEDURE WAS REQUIRED. ROUTINE FOLLOW UP CARE WAS ADMINISTERED ON (B)(6) 2016. FOLLOW UP CARE WAS AGAIN ADMINISTERED ON (B)(6) 2016 UNDER ANESTHESIA. THE ENGINEER WENT INTO CARDIAC ARREST AND LATER PASSED AWAY. THE INITIAL EVENT OCCURRED DURING SYSTEM INSTALLATION OF THE MAGNETOM SPECTRA AN THE SYSTEM WAS NOT YET TURNED OVER FOR CLINICAL OPERATION. THE TECHNICAL DOCUMENTATION FOR THE MAGNETOM SPECTRA INSTALLATION PROVIDES CLEAR WARNINGS AND INSTRUCTIONS REGARDING HELIUM FILLING. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT DURING SYSTEM INSTALLATION, A CONTRACTED SERVICE ENGINEER WAS HEAVILY BURNED ON HIS HANDS DURING HELIUM FILLING OF THE MAGNETOM SPECTRA SYSTEM. THE ENGINEER RECEIVED IMMEDIATE MEDICAL TREATMENT AND NO SURGICAL PROCEDURE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258226 MAGNETOM SPECTRA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. 10837643

    Patients

    Seq Age Sex Outcome Treatment
    1 Death