BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOMATOM DEFINITION FLASH

    MDR report key: 11057920 · Received December 22, 2020

    Report

    Report Number
    3004977335-2020-57468
    Event Type
    Death
    Date Received
    December 22, 2020
    Date of Event
    November 24, 2020
    Report Date
    February 9, 2021
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    JAK
    UDI-DI
    04056869006963
    PMA / PMN Number
    K190578
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS COMPLETED A DETAILED TECHNICAL INVESTIGATION OF THE REPORTED EVENT. THE ISSUE HAS BEEN IDENTIFIED AND SOLVED. AFTER REPLACEMENT OF THE LPS (LIGHT POSITION SENSOR FOR GANTRY ROTOR POSITION) AND THE CABLE W350 ON THE 29 DECEMBER 2020, THE CT SYSTEM IS STABLE AGAIN. THE MATERIAL CONSUMPTION IN RELATION TO THE INSTALLED BASE IS MONITORED BY OUR CAPA PROCESS (VALUES FOR THE LAST 3 MONTHS SEE BELOW). NO FURTHER INVESTIGATION WITHIN THE COMPLAINT PROCESS IS DEEMED NECESSARY. MAT# 7741015 - LPS UNIT - DECEMBER 2020: 0,16%, NOVEMBER 2020: 0,16%, OCTOBER 2020: 0,08%. MAT# 8902202 - W350 ELECTRICAL CONDUCTOR IS NOT LISTED IN THE SPARE PART CATALOGUE, THIS CABLE IS RARELY ORDERED VIA A SPECIAL "NON DEFINED SPARE PARTS" PROCESS. IT HAS BEEN ORDERED TWO TIMES SINCE 2020/01/01 UNTIL TODAY. THIS CABLE IS USED IN SEVERAL CT SCANNERS, THE TOTAL NUMBER OF GLOBALLY INSTALLED SYSTEMS IS 9305. NO GENERAL DESIGN ISSUE HAS BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER'S TELEPHONE NUMBER IS: (B)(6). SIEMENS HAS INITIATED A TECHNICAL INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE OF THE EVENT HAS NOT YET BEEN DETERMINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION AND RECEIPT OF ADDITIONAL INFORMATION FROM THE REPORTING FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS ON (B)(6) 2020 THAT A PATIENT EXPIRED AFTER A CT EXAMINATION ON (B)(6) 2020. THERE WAS A MALFUNCTION OF SOMATOM DEFINITION FLASH SCANNER WHICH CAUSED AN APPROXIMATE 20-MINUTE DELAY IN DIAGNOSIS. IT WAS NECESSARY TO REBOOT THE SYSTEM TWICE UNTIL IT WAS READY TO SCAN AGAIN. THE EXAMINATION WAS COMPLETED AFTER THE 20-MINUTE DELAY. THE SYSTEM LOG SHOWED THE FOLLOWING ERROR: "ROTATION MOTOR POSITION TIMEOUT." IT IS NOT CLEAR AT THIS TIME IF THE DELAY IN DIAGNOSIS CAUSED OR CONTRIBUTED TO THE DEATH OF THE PATIENT. ADDITIONAL INFORMATION FROM THE REPORTING FACILITY IS PENDING. THE REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522806 SOMATOM DEFINITION FLASH SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS HEALTHCARE GMBH 10430603 04056869006963

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death