BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE FLOOR

    MDR report key: 9580307 · Received January 13, 2020

    Report

    Report Number
    3004977335-2020-13460
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    December 27, 2019
    Report Date
    December 27, 2019
    Manufacturer
    SIEMENS HEALTHCARE GMBH- AT
    Product Code
    OWB
    PMA / PMN Number
    K181407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: AFFECTED SYSTEM, MATERIAL # AND SERIAL # HAS BEEN CORRECTED FROM THE INITIAL REPORT. 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, CS REPORTS, SYSTEM HISTORY AND SYSTEM LOG FILES. UPON INVESTIGATION THE SERVICE ENGINEER CHECKED THE SYSTEM AND FOUND A TRANSCEIVER (DVI-LWL-DVI SET) HARDWARE ISSUE. THE SERVICE ENGINEER REPLACED AND RETURNED THE TRANSCEIVER TO THE MANUFACTURER FOR A DETAILED INVESTIGATION. THE RETURNED TRANSCEIVER WAS EXAMINED IN DETAIL AND SHOWED THAT THE SENDER MODULE WAS BROKEN. NORMALLY THE LIVE IMAGES ARE DISPLAYED IN THE EXAMINATION ROOM AS WELL AS IN THE CONTROL ROOM. IN THIS CASE, NO LIVE IMAGES COULD BE DISPLAYED IN THE EXAMINATION ROOM, HOWEVER, THE VIEW IN THE CONTROL ROOM REMAINED. ALL OTHER SYSTEM FUNCTIONS ARE NOT AFFECTED. AFTER EXCHANGE OF THE AFFECTED TRANSCEIVER THE SYSTEM WORKED AS SPECIFIED. THE OCCURRENCE RATE OF THE IDENTIFIED CAUSE HAS BEEN CHECKED AND NO ERROR ACCUMULATION HAS BEEN IDENTIFIED. 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 · 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 ZEE BIPLANE SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT THE LIVE MONITOR IN THE EXAM ROOM 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
    45204 ARTIS ZEE FLOOR INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH- AT 10094135

    Patients

    Seq Age Sex Outcome Treatment
    1