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

Model Number	10848280
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Perforation (2001); Injury (2348)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
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 an adverse event occurred while operating the artis q floor system.The user reported bad image quality during an examination in which a patient suffered an arterial dissection.The dissection was repaired with a stent and there are no repercussions to the patients health.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.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.The customer reported that the image quality was not within the range of expectations, but the inspection of the system showed that it was working as specified.In order to meet the customer's requirements, the customer was instructed accordingly on site by application specialists.Some organ programs, which have an influence on the image quality, were optimized according to the customer's wishes.Additionally, the system has other organ programs which can be used at any time which meet worldwide requirements.The adequate handling of the system is described in detail in the user manual (ifu).The system has been checked on site by the local service organization and the customer has received additional training.The error has not been reported again.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: 10419310
• Report Number: 3004977335-2020-40212
• Device Sequence Number: 2942734
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10848280
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 10/15/2020
• 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: Required Intervention