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

Model Number	10848281
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Coma (2417)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10 additional manufacturer narrative: e1: customer facility contact name was not provided.Customer facility phone number is (b)(6).H3, h6: siemens has initiated a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available upon completion of the investigation.
Event or Problem Description
On 2023-07-03, the manufacturer was informed by its service organization that x-ray release was not possible using the artis q ceiling system.Additional information was received on 2023-07-20 (new awareness date) that the failure occurred during an emergency procedure and the patient had to be relocated to an alternative system to finish the medical procedure.The patient fell into a shallow coma.After the operation, the patient's vital signs were stable.After an inquiry to the customer, it was confirmed that the operation was successful, and the patient is no longer in a coma.
Additional Manufacturer Narrative
Siemens healthcare completed the investigation of the reported issue.The investigation was performed on expert discussions (considering complaint description, customer service reports, system history, and system log files.During an emergency procedure the message ¿no x-ray, tube too hot¿ was displayed on the monitor and x-ray release was not possible.According to the available information, the patient was in a shallow coma at the time.As a result, the procedure was continued and successfully finished using an alternative system.No health consequences to the patient were reported as a result of this event.A power cycle, performed by the user, resolved the issue at hand.Unfortunately, both an on-site service intervention and the detailed investigation of the log files did not provide a clear picture of how this error occurred.The corresponding error message displayed to the user usually indicates intensive x-ray use or reduced/defective cooling.However, neither could be confirmed by the log file analysis.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.

• Brand Name: ARTIS Q CEILING
• 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 HEALTHCARE GMBH; 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: 17386158
• Report Number: 3004977335-2023-00064
• Device Sequence Number: 6302298
• Product Code: OWB
• UDI-Device Identifier: 04056869009988
• UDI-Public: 04056869009988
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10848281
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 10/04/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown