MAUDE Adverse Event Report: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. ARTIS ONE; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	10848600
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The concerned unit was inspected by siemens local service.The engineer replaced the pc; the system is working according to the specifications following the pc replacement.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.(b)(4).
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis one system.During an interventional procedure, the pc froze, and the system went into the bypass mode.The user switched off the system and the power supply distributor and tried rebooting the unit.However, was unable to restart the device.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.The reported event occurred in china.
Additional Manufacturer Narrative
H10: siemens completed the investigation of the reported event using log analysis, returned part analysis, and customer feedback.It is concluded that the system malfunction was probably caused by malfunctioning hard disks (root cause).The investigation result showed the hard disks, rams and the battery on the motherboard were missing in the pc.Siemens integrated new hard disks, rams and battery in the returned pc and then performed tests for it.The pc was powered on successfully and worked normally.Considering onsite feedback when installing old disks in the temporary pc used for troubleshooting, blue screen and some database issues had occurred sporadically.It is most likely that the old hard disks were malfunctioning, causing the pc hang issue.A general systematic error has not been identified.Further action by siemens is not deemed necessary.H11 corrected data: b2: other serious or important medical events was checked on the initial report dated august 15, 2022 in error.The event is not an adverse event.It was a product problem.Internal id # (b)(4).

• Brand Name: ARTIS ONE
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen, 51805 7; CH 518057
• Manufacturer (Section G): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen 51805 7; CH 518057
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15225471
• Report Number: 3004754211-2022-38041
• Device Sequence Number: 5542193
• Product Code: OWB
• UDI-Device Identifier: 04056869009964
• UDI-Public: 04056869009964
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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: 10848600
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 11/10/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown