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

Model Number	10848281
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	10/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens conducted a retrospective review and re-evaluated this complaint.Siemens has now deemed that this complaint now meets the requirement for reporting under 21 cfr 803.Siemens has completed an investigation of the event.The root cause was determined to be a hardware error.Since the dipp (digital image pre-processing) boot up procedure did not start at all, based on expert discussion and experience, it is very likely that the flat panel detector receiver (fdr) board had a bad contact within the real time controller (rtc), which caused the fdr to lose its link to the rtc.The complete rtc was replaced by a service engineer and the error was not reported again.A possible error accumulation or even a systematic error, which would lead to a corrective action of the installed base, could not be determined by the investigation.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis q ceiling system.During an emergency procedure, the user 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 CEILING
• 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: 17392684
• Report Number: 3004977335-2023-50727
• Device Sequence Number: 6780124
• 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
• 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): 07/25/2023

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: 10848281
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 07/25/2023
• 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