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

Model Number	10848354
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2020
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 q ceiling system.During an interventional procedure, the user reported that no system movement was possible.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.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 of the log files does not indicate a system failure or malfunction and no non-conformity was identified.The investigation could not clearly clarify the cause of the error as the situation described by the customer had already been cleared up when the service technician arrived on site and could no longer be reproduced.While the actual cause of the problem could not be determined afterwards, the evaluation of the log file revealed that the so-called proximity switch of the c-arm, which is a protective function of the system that is supposed to prevent greater dangers or damage in the event of possible collisions, had been temporarily activated.In such events, movements are stopped in case of a detected collision or all further movements are switched to reduced speed.The purpose of this is to allow the user, under his supervision and control, to drive out of an accidentally activated collision zone in the opposite direction.As no defect could be detected on site, it can be assumed that the proximity switch in question was temporarily activated by a process similar to a collision (e.G.By touch).This would also explain the error message described by the customer.In this respect, the device would have functioned properly for such an unintended situation.The affected system has been checked by the local service organization and the error has not been reported again.The investigation revealed neither a system error nor any error accumulation.Therefore, no corrective action can be taken.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 CEILING
• 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: 10514078
• Report Number: 3004977335-2020-44030
• Device Sequence Number: 2682914
• Product Code: OWB
• UDI-Device Identifier: 04056869010021
• UDI-Public: 04056869010021
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

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: 10848354
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1