MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEE CEILING; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	10094137
Medical Device Problem Codes	Poor Quality Image (1408); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis zee ceiling system.The user reported artifacts on fluoro images during a perk cholecystostomy procedure.The procedure was successfully completed using an unltrasound.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 is conducting 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.Internal id # (b)(4).
Additional Manufacturer Narrative
Siemens conducted an investigation of the reported issue.During an onsite service intervention, a defective detector was identified.Following exchange of the defective part, the system was brought back to specifications.Detailed investigation revealed, that the cause of the image quality was an aging ram failure of the detector.Which occurred, after 11 years of operation.This type of error occurs, when the detector is disconnected from the power source.The failure does not occur, when the detector is on.In the described scenario, the error is obvious to the user, as following release of the first x-ray.Received images will display severe artifacts.The occurrence rate of the error pattern was checked by our experts.Possible error accumulation or systematic error, which may result in a corrective action of the installed base, could not be determined by the investigation.The incident described in the adverse event was not classified as a reportable event, after detailed investigation, because neither serious injury, death nor an unexpected prolonged hospitalization of the patient or any other person occurred or could be expected, since the corresponding probability according to the risk analysis is in the range of inconceivable.

• Brand Name: ARTIS ZEE CEILING
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 15462172
• Report Number: 3004977335-2022-43830
• Device Sequence Number: 3050805
• Product Code: OWB
• UDI-Device Identifier: 04056869010052
• UDI-Public: 04056869010052
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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: 09/07/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 09/21/2022
• Supplement Report FDA Received Date: 11/11/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown