MAUDE Adverse Event Report: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. ARTIS ONE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10848600

Device Problem Mechanical Problem (1384)

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

Event Date 06/28/2021

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 one system.During an interventional procedure, the user reported an error in which the collimator guard became active and the system movement was stopped.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

The investigation of the reported event was completed.The log files showed the device detected "guard active" information of the tube cover and the collimator; then system movement became restricted.According to the information provided by siemens local service, the user tried to loosen the collimator guard but without effect.According to siemens local service engineer, the tube cover was re-installed on the unit june 18, 2021, and force sensor calibration was performed as well.Presumably the sensor guard active was caused by the imperfect cover status after this service.The engineer checked the concerned tube cover assembly and performed the force sensor calibration june 30, 2021.The system was brought back to specifications.The engineer recommended to the user to perform "stand test" regularly to ensure that the force sensor calibration is being performed automatically.

• Brand Name: ARTIS ONE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; siemens mri center, gaoxin c.; hi-tech industrial park; shenzhen, china 51805 7; CH 518057
• MDR Report Key: 12141998
• MDR Text Key: 261678125
• Report Number: 3004754211-2021-86840
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K133580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10848600
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1