BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAGNETOM VERIO

    MDR report key: 6610451 · Received June 5, 2017

    Report

    Report Number
    3002808157-2017-03089
    Event Type
    Death
    Date Received
    June 5, 2017
    Date of Event
    May 30, 2017
    Report Date
    May 31, 2017
    Manufacturer
    SIEMENS HEALTHCARE GMBH, MR QT
    Product Code
    LNH
    PMA / PMN Number
    K072237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2017014. (B)(4). SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE MAGNETOM VERIO SYSTEM. A (B)(6) BABY WAS ANESTHETIZED FOR A CLINICAL PROCEDURE. FIVE MINUTES AFTER ANESTHETIZATION, THE BABY WAS INTRODUCED TO THE MR AREA TO INITIATE THE PROCEDURE. TWO MINUTES AFTER INTRODUCTION TO THE MR AREA, IT WAS REPORTED THE BABY PASSED AWAY. IT IS NOT KNOWN WHAT TYPE OF PROCEDURE WAS TO BE PERFORMED. ADDITIONALLY, THE CAUSE OF THE BABY'S DEATH IS UNKNOWN AND UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. ASSESSMENT OF THE LOG FILES DID NOT INDICATE A SYSTEM FAILURE OR MALFUNCTION AND NO NON-CONFORMITY WAS IDENTIFIED. A (B)(6) MONTH OLD BABY WAS ANESTHETIZED AND FIVE MINUTES LATER BROUGHT INTO THE MAGNETIC RESONANCE AREA TO INITIATE A PROCEDURE. TWO MINUTES LATER THE BABY PASSED AWAY. THE CUSTOMER PROVIDED INFORMATION THAT THE BABY HAD CONVULSED IN THE DAYS BEFORE THE PROCEDURE AND WAS SENT TO THE DIAGNOSTIC CENTER FOR A STUDY REQUESTED BY HIS NEUROLOGIST. ADDITIONALLY, THE CUSTOMER INDICATED THAT THE BABY WAS IN A DELICATE CONDITION AND THE DEATH WAS NOT CAUSED BY THE MR SYSTEM. UNFORTUNATELY, THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION ON THE CAUSE OF THE BABY'S DEATH. THE PROTOCOLS OF THE PREVENTIVE MAINTENANCE BEFORE THE ISSUE OCCURRED HAVE BEEN CHECKED. THE SYSTEM WAS ALSO CHECKED ON (B)(6) 2017 FOLLOWING THE PATIENT DEATH. BOTH CHECKS SHOWED THAT THE SYSTEM WAS OPERATING WITHIN SPECIFICATION AND OPTIMUM OPERATING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393328 MAGNETOM VERIO SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH SIEMENS HEALTHCARE GMBH, MR QT 10276755

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Death