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

Model Number	10094139
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
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 multi-purpose system.The user reported that the system used an image from a previous patient to create the roadmap image.At this time there is no report 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
The detailed investigation revealed that the system used an image of the correct patient to create the roadmap image, however, the image had poor quality.On-site investigations showed that the cause of the reported poor image quality was a disruption in the image data transmission chain.This temporary malfunction was eliminated by pulling and plugging the boards within the image acquisition system (ias).Following these steps, the unit works as specified.The affected ias has been fixed by the local service organization.The error has not reoccurred.

• Brand Name: ARTIS ZEE MULTI-PURPOSE
• 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: 10842484
• Report Number: 3004977335-2020-54440
• Device Sequence Number: 2960259
• Product Code: OWB
• UDI-Device Identifier: 04056869010076
• UDI-Public: 04056869010076
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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: 10094139
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1