MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH - AT ARCADIS ORDIC; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10143407
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporting facility phone number is: (b)(6) 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.
Event or Problem Description
It was reported to siemens that a malfunction occurred when using the arcadis ordic system.There was no display on the monitor and the patient images could not be displayed.There was no report of any adverse effect to the health status of the involved patient.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.As the customer neither notified our on-site service organization or forwarded details of this incident and, moreover, the on-site measures were not initiated by siemens but by the customer themself, the investigation could only be concluded on the basis of the available data.The hospital technician investigated the situation on site and found that the pc was not booting.According to his own information, all circuit boards within the pc m470 were cleaned, the software reloaded and system settings reconfigured.After that, the system was running properly again.Further information about the root cause would require a deeper analysis of the log files and an examination of the defective part.Unfortunately, neither of these is possible for the reasons stated above.The affected part has been repaired by a non-siemens organization.A possible general error, which 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 ORDIC
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - AT; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 11071890
• Report Number: 3004977335-2020-59707
• Device Sequence Number: 16971723
• Product Code: OWB
• UDI-Device Identifier: 04056869009025
• UDI-Public: 04056869009025
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042793
• 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): 12/24/2020

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: 10143407
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/24/2020
• Supplement Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1