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

Model Number	10848280
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
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 q floor system.The user reported that the image quality was in a range that multiple injections of the contrast medium with different exam sets was required in order to see the vessel.At this time, 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 user error.The detailed investigation showed that the situation was caused by incorrect operation.Both the on-site investigation and the review of the log file clearly indicated that the user had simply used the wrong program.The system has standard programs, with different parameters, depending on the purpose of use.In the given case, the user mistakenly wanted to use a program intended for abdominal images for neuro images, which is neither appropriate nor does it lead to the desired result.The respective application is described in detail in the user manual.To counteract the above-mentioned problem, the customer was again trained on the system.A possible fault of the system could not be determined by the examination.The system works as specified and no further measures are necessary.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 Q FLOOR
• 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: 11331638
• Report Number: 3004977335-2021-67912
• Device Sequence Number: 2581517
• Product Code: OWB
• UDI-Device Identifier: 04056869009971
• UDI-Public: 04056869009971
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 02/16/2021

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: 10848280
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1