MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG ARTIS ZEE CEILING; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10094137
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed if additional information becomes available.H6: 4755: unknown.
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis zee ceiling unit.During an emergency patient procedure, the system went into the bypass mode.The procedure was completed on an alternate system.We have no indications of any adverse effects on the health status of the involved patient.Siemens requested additional information regarding this event.
Additional Manufacturer Narrative
The investigation was completed by our experts.The log file showed that the component widescreen control unit was down and no communication to the multi display manager services was possible.The investigation could not identify a reason for lost communication.According to the experts, it is assumed that a temporary error caused the system to switch to bypass mode, which was resolved by restarting the system.The failure has not occurred again.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 primary udi number in section d4 was corrected.

• Brand Name: ARTIS ZEE CEILING
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; 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: 19054218
• Report Number: 3004977335-2024-00038
• Device Sequence Number: 20600394
• Product Code: OWB
• UDI-Device Identifier: 04056869010052
• UDI-Public: (01)04056869010052(21)148278
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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: 10094137
• 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: 03/16/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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