BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOMATOM DEFINITION FLASH

    MDR report key: 10507425 · Received September 9, 2020

    Report

    Report Number
    3004977335-2020-42304
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Date of Event
    August 13, 2020
    Report Date
    November 10, 2020
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    JAK
    UDI-DI
    04056869006963
    PMA / PMN Number
    K190578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS COMPLETED THE TECHNICAL INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE OF THE EVENT WAS IDENTIFIED AS A USE ERROR WHICH WAS FOUND BY THE SIEMENS DEVELOPER AFTER INVESTIGATING THE EVENT LOGFILES. THE SPIRAL SCAN AFTER MONITORING SCANS WAS ABORTED DUE TO AN INCORRECT HTP POSITION INFORMATION IN READINGS BECAUSE PATIENT TABLE STEP PLATE, BETWEEN THE GANTRY AND PHS, WAS PRESSED. IT WAS RELEASED APPROXIMATELY TWO MINUTES AFTER THE SCAN ABORT. NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 1

    SIEMENS HAS INITIATED A TECHNICAL INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED AND IT IS UNCLEAR IF THE SYSTEM MALFUNCTIONED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT DURING A CONTRAST ENHANCED CT SCAN OF A (B)(6)-MONTH OLD INFANT WITH THE SOMATOM DEFINITION FLASH SYSTEM, THE SCAN ABORTED IN THE MIDDLE OF THE SCAN. THE PARENT WAS STANDING NEXT TO THE GANTRY DURING THE EXAMINATION, WHEN THIS ISSUE OCCURRED. AFTER A REBOOT OF THE SCANNER, THE EXAMINATION COULD BE CONTINUED. CONSEQUENTLY, THE CHILD WAS RESCANNED, AND ADDITIONAL 7 ML OF CONTRAST MEDIA WAS GIVEN. AFTER THE CT EXAMINATION, A 4-HOUR SALINE DRIP NEEDED TO BE GIVEN TO THE PATIENT IN ORDER TO FLUSH CONTRAST. NO OTHER INJURY OF THE PATIENT HAS BEEN REPORTED EXCEPT THE ADDITIONAL XRAY DOSE, CONTRAST MEDIA AND NEED FOR THE SALINE DRIP. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972149 SOMATOM DEFINITION FLASH SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS HEALTHCARE GMBH 10430603 04056869006963

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO