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

Model Number 10848282

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/05/2021

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 biplane system.During an interventional procedure, the user reported a tube rotating problem.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 detailed investigation showed that the problem was based on a hardware defect.The rotating anode bearing of the x-ray tube, which is a consumable part, was defective and blocked.Rotation of the rotating anode was no longer possible.This could be reproduced on the returned part.A non-rotating rotating anode inevitably leads to the loss of x-ray radiation.Such a defect can only be eliminated by on-site service intervention and replacement of the affected part.Despite various qualitative precautions, such failures, which are due to technological reasons, cannot be completely avoided, especially since the bearing wear depends on the respective load.The spare parts consumption of the x-ray tube was checked and no abnormalities were found.A possible accumulation of faults or a possible general fault that would require corrective measures 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 BIPLANE
• 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: 12341357
• MDR Text Key: 267232330
• Report Number: 3004977335-2021-92080
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: 04056869009995
• 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: 08/19/2021

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: 10848282
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1