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

Model Number	10094139
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis zee mp system.During an interventional procedure, the user reported that the system went into bypass mode.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.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The investigation showed that the image acquisition system (ias) failed due to a defect in the ias computer, which was confirmed by the evaluation of the log files.As a result, the system switched to the bypass fluoro mode, as intended for such a case, and displayed a corresponding error message to the operator.This special mode, which is a mitigation of the problem, allows the system to continue generating imaging.However, neither acquisition nor storage or further processing of data is possible, and the image quality is reduced.Such an error can only be eliminated by replacing the affected hardware.The entire ias bb3.5 pc was replaced during service intervention.The system is running again as specified.The spare parts consumption of the affected part was checked.A possible error accumulation or even a possible general error, which would require corrective measures of the installed base, could not be determined by the investigation.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: ARTIS ZEE MP
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 12413670
• Report Number: 3004977335-2021-94259
• Device Sequence Number: 17059233
• Product Code: OWB
• UDI-Device Identifier: 04056869010076
• UDI-Public: 04056869010076
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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: 10094139
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1