BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOM ARTIS DFC

    MDR report key: 7086211 · Received December 6, 2017

    Report

    Report Number
    3004977335-2017-06677
    Event Type
    Death
    Date Received
    December 6, 2017
    Date of Event
    November 22, 2017
    Report Date
    November 23, 2017
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K052202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2017017. (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 AXIOM ARTIS DFC SYSTEM. DURING A PATIENT PROCEDURE, THE USER REPORTED DARK IMAGES FOLLOWED BY NO IMAGE WHEN THE TUBE WAS ANGLED DURING A CASE. THE PATIENT WAS CONSIDERED VERY HIGH RISK PRIOR TO THE EXAM START AND PASSED AWAY DURING THE PROCEDURE. AT THIS TIME, IT IS NOT KNOWN IF IMAGE QUALITY ISSUES WERE A CONTRIBUTING FACTOR IN THE PATIENTS DEATH.

    Additional Manufacturer Narrative · 1

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE INVESTIGATION CONFIRMED A DEFECTIVE X-RAY-TUBE-ASSEMBLY (XTA) AND THE XTA WAS NOT VOLTAGE PROOF IN THE RANGE OF 125 KV/380 MA. A SMALL CRACK IN THE GLASS HOUSING OF THE ANODE SITE COULD BE IDENTIFIED. LEAKY GLASS HOUSING LEADS TO A DECREASE OF THE INSULATING VACUUM INSIDE THE TUBE OR AT LEAST A CONTAMINATION OF THE SAME. THIS IN TURN LEADS TO X-RAY-TUBE ARCING AND IN A FINAL STATE TO NO AVAILABILITY OF X-RAY RESPECTIVELY TO THE ERROR DESCRIBED IN THE COMPLAINT. THE TUBE HAS BEEN EXCHANGED ON SITE BY THE LOCAL SERVICE ORGANIZATION AND THE ERROR DID NOT RECUR SINCE. THE MANUFACTURER IS NOT CONSIDERING FURTHER ACTIONS RESULTING FROM THIS EVENT BECAUSE NO ERROR BURST HAS BEEN RECOGNIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867770 AXIOM ARTIS DFC INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 7412807

    Patients

    Seq Age Sex Outcome Treatment
    1 Death