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 Codes	Computer Software Problem (1112); Battery Problem (2885); Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
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 a malfunction occurred while operating the arcadis avantic gen 2 system.During an interventional procedure, the user reported that the image processing pc crashed and the procedure start was delayed.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
The investigation of the reported was completed by siemens.The log files for the reported event were not available, however as the system crushed unexpectedly, this failure would not be recorded in the log files.The customer service engineer (cse) inspected the unit and determined the following causes of the issue - extremely low voltage of the bios battery and insufficient data area.The low voltage of the battery prevented the pc from loading the operating system.Meanwhile, the insufficient data area error means that the total memory usage had been exceeded.With the user's permission, the cse deleted the patient data and rebuilt the database.Following the hardware replacement, no further issues have occurred.The occurrence rate of the identified cause has been checked and no error accumulation has been identified.The occurrence rate is below the defined threshold.

• Brand Name: ARCADIS AVANTIC GEN 2
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 10828716
• Report Number: 3004977335-2020-54038
• Device Sequence Number: 2960379
• Product Code: OXO
• UDI-Device Identifier: 04056869009001
• UDI-Public: 04056869009001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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: 10143408
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1