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	10/17/2022
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.High dose was reported during an interventional procedure.Additional information was provided that the patient had no visible skin redness or other injuries; and the patient's condition was being monitored.Siemens has requested additional information in order to conduct an investigation of the reported event.The reported event occurred in germany.
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).
Event or Problem Description
Additional information.Siemens was informed that a high accumulated patient dose (24 gy) was applied, which occurred during a complex procedure (mitral valve replacement), that lasted more than five (5) hours and involved 373 fluoros and 211 acquisitions.The dose applied was real-time displayed on the monitor.According to the provided information, due to the patient's condition, the dose administered during this procedure was of lower priority.
Additional Manufacturer Narrative
Siemens healthcare completed the investigation of the reported event.The investigation was performed based on expert discussions considering the complaint description, customer service reports, and system history.Siemens was informed that a high accumulated patient dose (24 gy) was applied, which occurred in a complex procedure (mitral valve replacement), that lasted more than five (5) hours and involved 373 fluoros and 211 acquisitions.The dose applied was real-time displayed on the monitor.According to the provided information, due to the patient's condition, the dose administered during this procedure was of lower priority.Due to the high dose administered, the patient's state of health was monitored by the hospital regarding skin redness/skin damage on a long-term basis.Skin damage was observed as an undesired deterministic side effect in late november.The detailed technical investigation revealed that the recorded dose values are in accordance with the system settings and imaging conditions and comply with the applicable regulatory requirements.The system worked as specified.The occurrence rate of the aforementioned effect was checked.An accumulation could not be determined by the investigation.H11 corrected data: g2: report source "company representative" should not have been checked on the initial report submitted to the fda on october 31, 2022.Report source "other" should have been checked and germany listed in the corresponding field.H3: device had not been evaluated by manufacturer when the initial report was submitted.This field should have been checked "no".

• 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: 15698337
• Report Number: 3004977335-2022-49823
• Device Sequence Number: 8221145
• Product Code: OWB
• UDI-Device Identifier: 04056869149325
• UDI-Public: 04056869149325
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

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: 10/19/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 02/02/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown