BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS DFC

    MDR report key: 7532817 · Received May 22, 2018

    Report

    Report Number
    3004977335-2018-28974
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    May 4, 2018
    Report Date
    May 4, 2018
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K052202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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.

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE A FAILURE OF THE POWER SUPPLY TO THE UPS. DURING TROUBLESHOOTING THE SERVICE ENGINEER (CSE) FOUND A LOOSE, DISCONNECTED POWER CABLE ON THE UPS. AFTER RECONNECTING THE CABLE AND CHECKING THE PROPER OPERATION OF THE UPS, THE CSE POWER CYCLED THE COMPLETE SYSTEM. NO FURTHER ISSUE OF THE BSR APPLICATION COULD BE DETERMINED AFTER THE REPAIR. FULL SYSTEM FUNCTIONALITY WAS RESTORED. THE ANALYSIS OF THE LOG FILES SHOWED THAT DURING THE PROCEDURE, POWER SUPPLY TO THE UPS FAILED INTERMITTENTLY. THEREFORE, THE UPS SWITCHED TO BATTERY POWER. THE SYSTEM RAN ON UPS BATTERY POWER FOR ABOUT 2 MINUTES AT WHICH TIME THE UPS BATTERY TIMER EXPIRED AND INITIATED A SHUTDOWN EVENT TO THE BSR APPLICATION. THE BSR APPLICATION PROCESSED THE SHUTDOWN AND SWITCHED OFF THE ENTIRE LAB AND NO FURTHER IMAGING WAS POSSIBLE. THE SERVICE ENGINEER RECONNECTED THE POWER CABLE AND POWER CYCLED THE SYSTEM. NO PARTS NEEDED TO BE REPLACED AND THE ERROR DID NOT REOCCUR. NO FURTHER CORRECTIVE ACTION IS PLANNED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE AXIOM ARTIS DFC SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE X-RAY SCREEN WAS NOT AVAILABLE ON THE PANEL AND THE BUTTONS WOULD NOT RESPOND WHEN PUSHING THEM. THE PATIENT WAS SAFELY REMOVED FROM THE SYSTEM AND TRANSFERRED TO AN ALTERNATE SYSTEM WHERE THE PROCEDURE WAS COMPLETED. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374616 AXIOM ARTIS DFC INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 7412807

    Patients

    Seq Age Sex Outcome Treatment
    1