BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMATOM FORCE

    MDR report key: 5987115 · Received September 29, 2016

    Report

    Report Number
    2240869-2016-05147
    Event Type
    Injury
    Date Received
    September 29, 2016
    Date of Event
    September 2, 2016
    Report Date
    September 2, 2016
    Manufacturer
    SIEMENS HEALTHCARE GMBH, CT QT DCU
    Product Code
    JAK
    PMA / PMN Number
    K133589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAS CONDUCTED A THOROUGH INVESTIGATION OF THE REPORTED EVENT. IT WAS DETERMINED THAT A COMMUNICATION ERROR OCCURRED WITHIN THE UMAS CAUSING THE SYSTEM TO RESTART. AS THE REPORTED ERROR IS VERY SPORADIC, THE COMMUNICATION ERROR WILL BE RESOLVED IN THE NEXT SERVICE PACK RELEASE. ADDITIONALLY, THE PATIENT IS REPORTED TO HAVE SUFFERED NO LASTING HEALTH EFFECTS FROM THE PROCEDURE AND CONTRAST MEDIA. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED DURING A PROCEDURE ON THE SOMATOM FORCE RESULTING IN AN ADVERSE EVENT. A THREE DAY OLD PATIENT WAS SEDATED AND RECEIVED 5ML OF DILUTED IMERON 400 CONTRAST MEDIA. DURING THE PROCEDURE, THE TOPO STARTED BUT THE SPIRAL DID NOT START AND CAUSED A DELAY IN PROCEDURE. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE SYSTEM WHERE ANOTHER 5ML OF CONTRAST MEDIA WAS ADMINISTERED 26 MINUTES LATER. THE DELAY IN PROCEDURE DID NOT RESULT IN ANY HEALTH HARM TO THE PATIENT, HOWEVER, THE PATIENT RECEIVED TWICE THE AMOUNT OF CONTRAST MEDIA AND WAS EXPOSED TO A REPEAT TOPO EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638840 SOMATOM FORCE SYSTEM, XRAY, TOMORGRAPHY, COMPUTED JAK SIEMENS HEALTHCARE GMBH, CT QT DCU 10742326

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Other