MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG ARCADIS ORBIC GEN2; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

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	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed upon completion of the investigation.
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the arcadis orbic gen2 system.During an emergency procedure, no image was displayed on the monitor when the user tried to perform fluoro.The user tried to re-start the unit, but the system remained frozen.The patient was relocated to an alternate system to complete the procedure.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.The root cause was determined to be a software error.During an emergency procedure, no image was displayed on the monitor and the pc stopped working.The system was forcefully shut down, but the pc could not be powered on again.A blue screen was displayed.This blue screen is known as the blue screen of death (bsod).This occurs when windows encounters a critical failure and is forced to crash and stop working.The only solution at this point is restarting the pc, even though this may lead to data loss.The customer service engineer (cse) reseated the hard drive, and the issue was resolved.The occurrence rate of the error pattern was checked.A possible error accumulation or even a systematic error, which would lead to a corrective action of the installed base, could not be determined by the investigation.

• Brand Name: ARCADIS ORBIC GEN2
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 19623581
• Report Number: 3004977335-2024-00068
• Device Sequence Number: 15036650
• Product Code: OXO
• UDI-Device Identifier: 04056869009025
• UDI-Public: (01)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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown