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

Model Number	10848282
Medical Device Problem Codes	No Device Output (1435); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis q biplane system.During an emergency procedure, the machine went into the bypass mode.The user tried to reboot the unit but was unable to bring the system back up.The patient had to be moved to an alternate unit.We are unaware of any adverse impact to the state of health of the patient involved.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.As this event is under investigation yet been determined.A supplement report will be filed if additional information becomes available.
Additional Manufacturer Narrative
The investigation was completed by our experts.The investigation revealed that the reported issue was caused by a defective hard drive disk (hdd) in the real time controller (rtc) after 10 years of operation.To resolve the issue, the rtc was replaced.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.
Additional Manufacturer Narrative
H10: e1: initial reporter state was added.G4: 510(k) was added.H11: corrected data: d4: complete udi number added.H11: corrected data: d4: complete udi number added.

• Brand Name: ARTIS Q BIPLANE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 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: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17985649
• Report Number: 3004977335-2023-00135
• Device Sequence Number: 20874708
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: (01)04056869009995(21)121012
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2024

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: 10848282
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: 12/12/2023; Not provided
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 12/13/2023; 07/22/2024
• 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