BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMATOM FORCE

    MDR report key: 8150619 · Received December 11, 2018

    Report

    Report Number
    3004977335-2018-59965
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 21, 2018
    Report Date
    November 29, 2018
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    JAK
    PMA / PMN Number
    K173630
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2017017. SIEMENS HEALTHINEERS MALVERN USA (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF SIEMENS HEALTHCARE GMBH, FORCHHEIM (MANUFACTURER). SIEMENS COMPLETED THE TECHNICAL INVESTIGATION OF THE REPORTED EVENT. THE X-RAY TUBE WAS REPLACED IN DECEMBER 2018. THE SYSTEM DID NOT EXPERIENCE ANY ADDITIONAL ISSUES SINCE THE TUBE WAS CHANGED. THE INVESTIGATION DID NOT IDENTIFY ANY GENERAL PRODUCT DEFICIENCIES. ADDITIONAL ACTION IS NOT WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2017017. (B)(4). SIEMENS HAS INITIATED A TECHNICAL INVESTIGATION OF THE REPORTED EVENT. DOSE CALCULATION IS ALSO BEING PERFORMED. A ROOT CAUSE HAS NOT YET BEEN IDENTIFIED. A SUPPLEMENTAL REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION. (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT DURING USE OF SOMATOM FORCE DEVICE, TWO SCANS WERE ABORTED, RESULTING IN THE INFANT PATIENT HAVING TO UNDERGO TWO ADDITIONAL SCANNING PROCEDURES. THE USER REPORTED "THE CHILD IS FINE TO DATE"; HOWEVER, THERE IS CONCERN REGARDING THE DOSE AND ADDITIONAL CONTRAST MEDIUM RE-INJECTION. THERE WAS CONCERN FOR THE PATIENT'S KIDNEYS DUE TO THE ADDITIONAL CONTRAST INJECTIONS. AFTER THE TEST RESULTS FOR THE PATIENT'S KIDNEYS BECAME AVAILABLE, A THIRD SCAN OF THE PATIENT WAS PERFORMED ON (B)(6) 2018. THE THIRD SCAN WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992199 SOMATOM FORCE SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS HEALTHCARE GMBH 10742326

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA Other