BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS PHENO

    MDR report key: 12967971 · Received December 9, 2021

    Report

    Report Number
    3004977335-2021-07884
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    December 3, 2021
    Report Date
    December 9, 2021
    Manufacturer
    SIEMENS HEALTHCARE GMBH-AT
    Product Code
    OWB
    UDI-DI
    04056869046877
    PMA / PMN Number
    K201156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE A PERFORMANCE ERROR. WHILE PREPARING FOR A PROCEDURE, NO IMAGE WAS DISPLAYED ON THE THE LARGE DISPLAY (LD). A REPEATED RESTART OF THE SYSTEM PERFORMED BY THE USER RESOLVED THE PROBLEM. SIEMENS SERVICE WAS CALLED TO CHECK THE SYSTEM. SINCE THE ON-SITE TROUBLE SHOOTING DID NOT REVEAL A CLEAR CAUSE FOR THE REPORTED PROBLEM, THE TRANSCEIVER MODULE, WHICH TRANSMITS THE IMAGES TO THE LD, WAS REPLACED AS A PROACTIVE MEASURE. UPON THE INVESTIGATION OF THE REPLACED PART, NO FAULT WAS FOUND, BUT FROM INVESTIGATION OF THE LOG FILES IT WAS POSSIBLE TO DETERMINE THAT THERE WAS A PERFORMANCE PROBLEM WITH THE LAB COMMUNICATION INTERFACE (LCI) COMPONENT. THE LCI CRASHED, WHICH CAUSED THE X-RAY RELEASE TO BE BLOCKED AND NO IMAGE WAS DISPLAYED AS A RESULT. USER WAS ALERTED TO THIS PROBLEM BY THE DISPLAYED ERROR MESSAGE "NO XRAY, BYPASS FLUORO NOT POSSIBLE". THIS PROBLEM COULD ONLY BE FIXED BY RESTARTING THE SYSTEM. THE INSTRUCTIONS FOR USE (IFU) CONTAIN SUFFICIENT INFORMATION IN THE EVENT THAT X-RAY RELEASE IS NOT POSSIBLE. A POSSIBLE GENERAL ERROR THAT WOULD REQUIRE CORRECTIVE MEASURES OF THE INSTALLED BASE COULD NOT BE DETERMINED BY THE INVESTIGATION. AFTER DETAILED INVESTIGATION, THE INCIDENT IS NOT CLASSIFIED AS A REPORTABLE EVENT AS NEITHER SERIOUS INJURY, DEATH NOR AN UNEXPECTED, PROLONGED HOSPITALIZATION OF THE PATIENT OR ANY OTHER PERSON OCCURRED OR COULD BE EXPECTED.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS PHENO SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT THE LARGE DISPLAY WAS DARK. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT 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
    1865182 ARTIS PHENO INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH-AT 10849000 04056869046877

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown