BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS BI-PLANE IMAGING SYSTEM

    MDR report key: 11581195 · Received March 29, 2021

    Report

    Report Number
    11581195
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    February 26, 2021
    Report Date
    March 1, 2021
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    IZI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 0

    THE IMAGE QUALITY WAS REALLY POOR WITH THE ADVANCED APPLICATIONS. XX CAME EXTRA TO HELP US BECAUSE WE HAD TWO CASES GOING FOR NEURO AND SHE COULD NOT FIGURE OUT WHY THE 3DRA LOOKED BAD. DR. CAME DOWN AND GOT ME TO HELP TROUBLESHOOT. I COULD NOT MAKE THE IMAGE LOOK BETTER BY MANIPULATIONS, SO WHEN WE DID THE SPIN ON THE OTHER SIDE, I HAD MADE ADJUSTMENTS TO SEE IF THE QUALITY WAS ANY BETTER. IT WAS NOT. THIS TIME WITH DR. BEING THERE FOR THE ENTIRE PROCESS; THE A-PLANE C-ARM SHOOK THROUGHOUT THE SPIN, WHICH CREATED MOTION THAT COULD NOT BE ADJUSTED OUT OF THE IMAGE, AND THEN DEGRADED THE IMAGE TO THE POINT THAT DR. HAD SAFETY CONCERNS FOR TREATMENT PLANNING. I TRIED TO MAKE IT BETTER WITH LITTLE SUCCESS. AT THE END, WE HAD TO DO A CT ON THE TABLE DUE THE PATIENT CONDITION POSSIBLE CHANGING. THE CT WAS ALSO POOR QUALITY, FILLED WITH MOTION. THE PATIENT DID NOT MOVE. THE PATIENT WAS INTUBATED WITH THEIR HEAD TAPED TO THE TABLE. ON THE RAW DATA PRIOR TO THE PROCESSING OF THE DATA TO THE WORKSTATION, THE MOTION OF THE C-ARM IS ACTUALLY VISUALIZED. NEXT, THERE IS A RADIATION SAFETY CONCERN. EVEN THOUGH WE DID 2 SPINS AND 1 CT WITH A FEW DSA RUNS, THE A-PLANE WAS AT 3.4G. THAT IS A BIG PROBLEM. IT SHOULD NOT BE THAT HIGH FOR THE LITTLE WORK WE DID. PER DR., THIS IS THE SECOND TIME THIS HAPPENED. DR. WANTED ME TO POINT OUT AS WELL THAT WE HAD 198 MINUTES OF FLUORO AND THAT WAS THE AVF EMBO FROM 12:00PM TO 21:00 HOURS AND ON THE A-PLANE WE ONLY HAD 1.8G AND ON THE B-PLANE WE ONLY HAD 1.0G. WE DID NOT DO ANY SPINS, HOWEVER THAT WAS A LONG PERIOD OF TIME WITH A LOT OF FLUORO AND WE DID NOT EVEN GET CLOSE TO WHAT DR. HAD IN THE OTHER ROOM WITH ONLY 29 MINUTES OF FLUORO AND 3.4G ON THE A-PLANE.

    Description of Event or Problem · 1

    THE IMAGE QUALITY WAS REALLY POOR WITH THE ADVANCED APPLICATIONS. XX CAME EXTRA TO HELP US BECAUSE WE HAD TWO CASES GOING FOR NEURO AND SHE COULD NOT FIGURE OUT WHY THE 3DRA LOOKED BAD. DR. CAME DOWN AND GOT ME TO HELP TROUBLESHOOT. I COULD NOT MAKE THE IMAGE LOOK BETTER BY MANIPULATIONS, SO WHEN WE DID THE SPIN ON THE OTHER SIDE, I HAD MADE ADJUSTMENTS TO SEE IF THE QUALITY WAS ANY BETTER. IT WAS NOT. THIS TIME WITH DR. BEING THERE FOR THE ENTIRE PROCESS; THE A-PLANE C-ARM SHOOK THROUGHOUT THE SPIN, WHICH CREATED MOTION THAT COULD NOT BE ADJUSTED OUT OF THE IMAGE, AND THEN DEGRADED THE IMAGE TO THE POINT THAT DR. HAD SAFETY CONCERNS FOR TREATMENT PLANNING. I TRIED TO MAKE IT BETTER WITH LITTLE SUCCESS. AT THE END, WE HAD TO DO A CT ON THE TABLE DUE THE PATIENT CONDITION POSSIBLE CHANGING. THE CT WAS ALSO POOR QUALITY, FILLED WITH MOTION. THE PATIENT DID NOT MOVE. THE PATIENT WAS INTUBATED WITH THEIR HEAD TAPED TO THE TABLE. ON THE RAW DATA PRIOR TO THE PROCESSING OF THE DATA TO THE WORKSTATION, THE MOTION OF THE C-ARM IS ACTUALLY VISUALIZED. NEXT, THERE IS A RADIATION SAFETY CONCERN. EVEN THOUGH WE DID 2 SPINS AND 1 CT WITH A FEW DSA RUNS, THE A-PLANE WAS AT 3.4G. THAT IS A BIG PROBLEM. IT SHOULD NOT BE THAT HIGH FOR THE LITTLE WORK WE DID. PER DR., THIS IS THE SECOND TIME THIS HAPPENED. DR. WANTED ME TO POINT OUT AS WELL THAT WE HAD 198 MINUTES OF FLUORO AND THAT WAS THE AVF EMBO FROM 12:00PM TO 21:00 HOURS AND ON THE A-PLANE WE ONLY HAD 1.8G AND ON THE B-PLANE WE ONLY HAD 1.0G. WE DID NOT DO ANY SPINS, HOWEVER THAT WAS A LONG PERIOD OF TIME WITH A LOT OF FLUORO AND WE DID NOT EVEN GET CLOSE TO WHAT DR. HAD IN THE OTHER ROOM WITH ONLY 29 MINUTES OF FLUORO AND 3.4G ON THE A-PLANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479174 SIEMENS BI-PLANE IMAGING SYSTEM SYSTEM, X-RAY, ANGIOGRAPHIC IZI SIEMENS HEALTHCARE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 17520 DA