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

Model Number 10848354

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  malfunction  

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 Description

It was reported to siemens that a malfunction occurred while operating the artis q.Zen ceiling system.During an interventional procedure, the user reported that no 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.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The analysis of this case showed that the error described occurred due to a hardware defect.The limit switch of the collision protection of the c-arm was defective.In this case, the c-arm of the system could no longer be moved by motor at full speed, but only at reduced speed in override mode for safety reasons.The patient couch was not affected by this.The reduced speed or the override mode mentioned is an intended mitigation for such a case and is also described accordingly in the instruction for use.The affected part was not available for examination; therefore, the examination result was based on expert opinions, the log file, and the findings on site.The limit switch was damaged by external influence, which can be caused by a collision with external objects.After replacing the limit switch, the system again functioned as specified.The spare parts consumption of the affected part was checked and a possible general fault that would require corrective action of the installed base could not be determined by the investigation.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.ZEN CEILING
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 11257812
• MDR Text Key: 231785804
• Report Number: 3004977335-2021-65383
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869010021
• UDI-Public: 04056869010021
• Combination Product (y/n): N
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10848354
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1