MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-AT ARCADIS AVANTIC GEN 2; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number	10143408
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the arcadis avantic gen 2 system.During an interventional procedure, the user reported that the images were over-exposed.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.
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.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.During an interventional procedure the image quality was compromised.The images were overexposed and the user was informed of this problem with a "collimator" error message.The procedure was continued and finished using an alternative system.Detailed investigation revealed that the error was due to a hardware problem.A gear in the collimator had a mechanical defect due to wear.The correction of the gear resolved the problem.In this kind of failure scenario the system is not blocked and in most of the cases the user can complete the procedure, despite the slot diaphragm failure.The procedure can be aborted in a controlled manner.A possible general error that would require corrective measures of the installed base could not be determined 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: ARCADIS AVANTIC GEN 2
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 6104486461
• MDR Report Key: 12982572
• Report Number: 3004977335-2021-07555
• Device Sequence Number: 5565168
• Product Code: OXO
• UDI-Device Identifier: 04056869009001
• UDI-Public: 04056869009001
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K051133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021

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: 10143408
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/10/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown