MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEEGO; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10280959
Medical Device Problem Code	Radiation Overexposure (3017)
Health Effect - Clinical Code	Radiodermatitis (2255)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported to siemens that an adverse event occurred following examination on the artis zeego system.Following an interventional procedure on (b)(6) 2020, a patient suffered an unconfirmed skin injury of radiodermatitis.Investigation at the time of the event did not confirm an abnormal radiation dose.Siemens has become aware of new information on may 17, 2021, that suggests the possibility of an excessively high radiation dose.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.Assessment of the log files does not indicate a system failure or malfunction and no non-conformity was identified.The root cause was determined to be a user error.The detailed investigation showed that the injury was not due to a malfunction of the system.Although it could be determined that individual dose registrations were not displayed or recorded due to a temporary problem, which had already been eliminated by replacing the relevant part, this was not the reason for the relatively substantial total dose.The evaluation of the event log, exam protocol and dose report, respectively the recalculation of the missing values, clearly showed that the radiation or its triggering was intentionally applied by the operator.Although the dose demanded by the operator without an additional copper prefilter corresponds to relatively long digital subtraction angiography (dsa) sequences with a relatively high frame rate and a considerable radiation output, it is assumed that the operator applied said dose after weighing all risks.A possible general error which would require corrective measures of the installed base could not be detected 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.

• Brand Name: ARTIS ZEEGO
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 11847394
• Report Number: 3004977335-2021-67061
• Device Sequence Number: 11640278
• Product Code: OWB
• UDI-Device Identifier: 04056869010083
• UDI-Public: 04056869010083
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K181407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10280959
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 05/27/2021
• 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