MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ICONO FLOOR; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	11327700
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis icono floor system.The user reported during an interventional procedure signals were displayed in inadequate quality on the large display.The procedure was continued and finished on the concerned system.There is no report of 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.The reported event occurred in switzerland.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.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.Internal id # (b)(4).
Additional Manufacturer Narrative
H10: siemens completed the investigation of the reported event.The investigation was performed based on expert discussions (considering complaint description, customer service reports, system history, system log files, and simulation).According to information provided, the quality of electrocardiogram (ecg) waveforms was not sufficient for electrophysiologists (ep) when the segments are scaled down on the large display in the examination room.However, the quality of the images in the control room are reflected in the desired quality.For patient procedures ep customer needs to display multiple external inputs which contain intracardiac ecg (iecg) waveforms on the large display.Since the live segment must have 996 x 960 pixels, these external sources only can be displayed at the same time on the large display when they are scaled down.The quality of iecg waveforms is affected when segments are scaled down.Simulation at the factory has confirmed that the reported problem is due to scaling.For correct display, a native display (e.G.Eizo monitor 1600 x 1200), such as is available in the control room, must be used, which displays the curves in the desired quality and can thus be used for diagnosis.Therefore, an additional monitor was installed next to the large display by the local service organization.The incident was not classified as an adverse event after detailed investigation, because neither serious injury, death nor an unexpected or prolonged hospitalization of the patient or any other person occurred or could be expected.The corresponding probability according to the risk analysis is in the range of inconceivable.Internal id # (b)(4).

• Brand Name: ARTIS ICONO FLOOR
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1 or rittigfeld 1; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15327203
• Report Number: 3004977335-2022-41463
• Device Sequence Number: 5374757
• Product Code: OWB
• UDI-Device Identifier: 04056869149325
• UDI-Public: 04056869149325
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K193326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11327700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown