BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS PHENO

    MDR report key: 8665920 · Received June 4, 2019

    Report

    Report Number
    3004977335-2019-81894
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    April 11, 2019
    Report Date
    May 15, 2019
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K163286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE A HARDWARE ISSUE. THE INVESTIGATION WAS PERFORMED CONSIDERING COMPLAINT DESCRIPTION, SYSTEM LOG FILES, SYSTEM HISTORY AND ON-SITE INVESTIGATION. THERE WAS A SPORADIC COMMUNICATION INTERRUPTION (LOST CONNECTIONS) BETWEEN THE ARTIS SYSTEM CENTRAL COMPUTING (CCOM) BOARD AND COMMUNICATION (COM) - BOARD OF THE MAQUET TABLE. AS A PRECAUTION, THE SYSTEM GOES INTO REDUCED SPEED WHERE ONLY MANUALLY CONTROLLED STAND MOVEMENTS ARE AVAILABLE. WITH THE SEPARATE MAQUET REMOTE CONTROL, A TABLE MOVEMENT WITH NORMAL SPEED IS STILL POSSIBLE. IN THIS CASE IT IS POSSIBLE TO RECOVER THE SYSTEM BY PERFORMING THE DESIGNATED TABLE-SPECIFIC RECOVERY PROCEDURE (RESTART OF THE MAQUET TABLE ACCORDING TO ACCOMPANYING DOCUMENT) OR BY PERFORMING THE DESIGNATED ARTIS-SPECIFIC RECOVERY PROCEDURE (RESTART THE ARTIS SYSTEM ACCORDING TO ACCOMPANYING DOCUMENT). BOTH RECOVERY OPTIONS ARE RECORDED BY THE SYSTEM AND SAVED IN THE LOG FILE. THE CUSTOMER SERVICE ENGINEER CHECKED AND REPLUGGED THE CONNECTORS, DISMOUNTED/REMOUNTED RELEVANT COMPONENTS OF THE MAQUET TABLE AS WELL AS ARTIS SYSTEM. NO FURTHER DISTURBANCES IN THE COMMUNICATION CHANNEL WERE OBSERVED. THE MANUFACTURER IS NOT CONSIDERING FURTHER ACTIONS RESULTING FROM THIS EVENT AS NO SYSTEMATIC ERROR HAS BEEN RECOGNIZED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS PHENO SYSTEM. THE CUSTOMER REPORTED NO COMMUNICATION BETWEEN THE ARTIS PHENO SYSTEM AND A MAQUET MAGNUS SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460836 ARTIS PHENO INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10849000

    Patients

    Seq Age Sex Outcome Treatment
    1