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

Model Number 10094137

Device Problem No Apparent Adverse Event (3189)

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

Event Date 07/05/2021

Event Type  malfunction  

Manufacturer Narrative

A facility contact name was not provided to siemens.The event was reported to siemens by a siemens employee.Siemens has initiated a detailed investigation of the reported event.A root cause has not yet been identified.Siemens will submit a supplemental report with the results of the investigation when it has been completed.

Event Description

It was reported to siemens that a malfunction occurred when using the artis zee ceiling system.During an interventional patient procedure, the system image quality was poor, and the procedure was continued and finished using an alternative system.At this time, there is no indication of any adverse health effects to the patient associated with this event.Detailed event clarification is currently being investigated by siemens.This report has been submitted with an abundance of caution.The reported event occurred in (b)(6).

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The investigation was performed considering complaint description, cs reports, system history, system log files, and cc-part.The investigation showed that the issue was caused by an arcing x-ray tube, which is an expendable item.Arcing is a side effect when generating x-ray.Negative effects from arcing are managed by the system in a way that there is no significant impact to the clinical procedure.If arcing exceeds a certain level, there is no x-ray release possible during arcing.Further imaging can be continued after arcing stops.In this case a medium level arcing was detected and had an impact on the clinical procedure.Individual scene may be interrupted and under certain conditions the scene may need to be reacquired.The customer service engineer (cse) replaced the x-ray tube and returned the part to the manufacturer for detailed investigation.After the part was replaced, the system recovered, and the system worked as intended.The returned x-ray tube was examined in detail.During first analysis the inductivity value of the small focus was as expected.The measured voltage value of the large focus and of the micro focus was not in the range of the specification.After disassembling the tube insert the root cause could be confirmed as a loss of hv stability.Additionally, the tube showed arcing evidence during the technician inspection which is an indication that the tube lost its vacuum stability and was not voltage proof anymore.The occurrence rate of the identified cause has been checked and no error accumulation has been identified.The occurrence rate is below the defined threshold; therefore, no corrective action is necessary.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 CEILING
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - AT; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 12189697
• MDR Text Key: 262242374
• Report Number: 3004977335-2021-87806
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869010052
• UDI-Public: 04056869010052
• 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,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/05/2021

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
• Device Operator: Health Professional
• Device Model Number: 10094137
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/05/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 10/25/2021
• Supplement Dates FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1