MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-AT ARTIS Q BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10848282
Medical Device Problem Codes	Output Problem (3005); Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens conducted a retrospective review and re-evaluated this complaint.Siemens has now deemed that that this complaint now meets the requirement for reporting under 21 cfr 803.The detailed investigation revealed that the cause of the blocked x-ray release was a temporary problem in the internal signal processing.In regular intervals the hardware is checked automatically.Within this check, the signal line between relevant sensors and the evaluation component is tested.The test is triggered when a relay switches the contact to the sensors off and back on.The d1 board detects the falling edge and checks that the voltage drops below a defined "low" level and remains like that for a defined, short period of time.In the present case, it was found that the contact of the relay showed bounce effects/voltage fluctuations.This triggered multiple, successive falling edges that repeated the cable test.However, since the voltage must remain in the "low" state for a certain time for the test to pass, this caused the test to fail even though there was no fault on the signal line.As a result, the x-ray release was prevented to avoid possible severe damage to the x-ray tube.Normal operation of the system was restored by a restart.A field safety corrective action (fsca ax028/22/s) and customer safety advisory notice (csi ax029/22/s) for the installed base was released in august 2022.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis q biplane system.During an emergency procedure, it was reported that x-ray could not be released.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.

• Brand Name: ARTIS Q BIPLANE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1- or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1- or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 17386116
• Report Number: 3004977335-2023-51673
• Device Sequence Number: 20397970
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: 04056869009995
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 07/24/2023

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: 10848282
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 07/24/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown