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

Model Number	10143406
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
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 varic gen 2 system.During an emergency procedure, the user reported that the system displayed an error message and the system was no longer operable.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 has completed an investigation of the reported event.The root cause was determined to be a hardware error.The detailed investigation showed that the error was due to a cable break within the c-arm.This led to the error message "error asp_msy_7009: slot diaphragm failure" and ultimately caused the slit diaphragm to fail and overexpose the image.The customer could still proceed with the examination and improve the image quality by: stopping the "adr" (automatic dose control) mode, positioning the c-arm appropriately, using the x-iris collimator, using additional zoom levels, and/or manually adjusting the image quality, however, the customer decided to switch to a different system.The service technician used a replacement cable, which is already present in the system's cable harness and is intended for such purposes, to resolve the error.The system was tested for function and is working as specified.The spare parts consumption was checked and a possible general fault 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 VARIC 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: 11357508
• Report Number: 3004977335-2021-68180
• Device Sequence Number: 11616896
• Product Code: OXO
• UDI-Device Identifier: 04056869009018
• UDI-Public: 04056869009018
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

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: 10143406
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1