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

Model Number	10848282
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis q biplane unit.During an emergency procedure, no x-ray exposure was possible.The procedure was successfully completed on an alternate unit.We have no indications of any adverse effects on the health status of the involved patient.
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.H6: 4756 - unknown.
Additional Manufacturer Narrative
The investigation was completed by our experts.Analysis of the log files showed that there was a temporary problem with the multi display manager (mdm), which was resolved by a system restart.The unit was checked by siemens local service engineer, who was unable to reproduce the reported issue.The issue has not returned since the first occurrence.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.The incident described in the adverse event is not classified as a reportable event after a thorough investigation because neither serious injury, death, nor unexpected prolonged hospitalization of the patient or other person occurred or is to be expected, even if the incident recurs.
Additional Manufacturer Narrative
7/18/2024: supplemental mdr 2 was submitted to the fda for correction of the primary udi number in section d4.

• 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: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 18006530
• Report Number: 3004977335-2023-00139
• Device Sequence Number: 6538010
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: (01)04056869009995(21)121137
• Combination Product (Y/N): N
• 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): 07/18/2024

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: 10/23/2023
• Supplement Date Received by Manufacturer: 12/18/2023; 07/18/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 12/18/2023; 07/18/2024
• 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