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

Model Number	10094143
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter telephone number is: (b)(6).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 upon completion of the investigation.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis zee biplane mn system during an interventional procedure.The procedure was continued and finished using an alternate system.At the time of this report, adverse impact to the patient's health as a result of this event has not been reported to siemens.Siemens has requested additional information in order to investigate the reported event.The reported event occurred in (b)(6).
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 error was caused by a hardware fault in a supplier part.In the investigation analysis it was found that a capacitor of the 8v power supply of the flat panel detector (fd) had dried out, which led to the loss of the supply voltage.Since the flat panel detector could no longer be operated, the system correctly prevented the triggering of radiation.This is an intended and specified mitigation to protect the patient.The affected 8v power supply has been exchanged by the local service organization.After replacing the affected power supply, the system again functioned faultlessly.The check of the database could not detect any error accumulation or systematic error.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 BIPLANE MN
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - AT; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10260222
• Report Number: 3004977335-2020-36200
• Device Sequence Number: 2603148
• Product Code: OWB
• UDI-Device Identifier: 04056869010106
• UDI-Public: 04056869010106
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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 Health Care Professional
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

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: 10094143
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1