MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARCADIS VARIC GEN2; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	10143406
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, siemens became aware of a malfunction that occurred while operating the arcadis varis gen 2 system.On november 16, 2022 information was received that the issue occurred during an emergency procedure when the user started fluoro, however, several seconds later the software froze.The user restarted the system, but the issue recurred.The procedure was completed on an alternate unit.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 event.A supplement report will be filed if additional information becomes available.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 the complaint description, customer service reports, and system history.According to available information, the software was frozen at the start of the system use.As a result, the procedure was continued and finished using an alternative system.During the onsite service intervention, the system started normally, and the described error scenario could not be reproduced.However, the error codes submitted confirmed that there were problems with database access and software.Based these findings, the inside of the pc was cleaned, the internal hardware (e.G., ram, boards) was checked, the bios battery was preventively exchanged, and the software was completely restored.The error mentioned in the complaint has not recurred and has not been reported since the onsite visit.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.The incident described was not classified as a reportable adverse event after detailed investigation.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.

• Brand Name: ARCADIS VARIC GEN2
• 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: 15885624
• Report Number: 3004977335-2022-52158
• Device Sequence Number: 5298453
• Product Code: OXO
• UDI-Device Identifier: 04056869009018
• UDI-Public: 04056869009018
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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: 10143406
• 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: 11/16/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 01/18/2023
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown