MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEEGO III; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10502505

Device Problem Radiation Output Failure (4027)

Patient Problem Paralysis (1997)

Event Date 07/29/2023

Event Type  malfunction  

Manufacturer Narrative

The device listed in section d of this report is not an fda 510(k) cleared medical device but is similar to the artis zee device which is cleared in the united states under k181407.Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.

Event Description

Siemens became aware of a malfunction while operating the artis zeego iii system.The user reported that during an emergency patient procedure, no x-ray could be released.August 8, 2023, additional information was received that the patient was diagnosed with cerebral infarction and was paralyzed.Siemens requested additional information to proceed with the investigation.

Manufacturer Narrative

The investigation of the reported event was completed by siemens experts.According to the provided information, the patient was found abnormal, and 8 hours later the diagnostic procedure showed a cerebral artery stenosis with cerebral infarction.As the in-house angiography x-ray system was found to be defective, the patient was transferred to a different facility, which caused a delay of 3 hours.The procedure was then completed on an alternate system 4 hours later.The patient's health consequences are reported as being paralyzed on one side with level three muscle strength.The extent to which the failure of the system contributed to the patient's outcome cannot be assessed in the provided context.The symptoms have been already present for at least 8 hours prior to treatment.The optimal time window for treatment of less than 6 hours has been already closed.Within a period of 24h a mechanical thrombectomy is beneficial only in specific patient subgroups.The analysis of the log-files showed that after approximately 20 minutes of system operation, a message "tube hot, have a break" was displayed to the user.This was an indication of a high tube temperature due to intensive x-ray usage by the operator or reduced/defective cooling.When such messages are displayed by the system, x-ray release is still possible, as a multi-level detection and warning mechanism is being activated.In such cases, the system would display an appropriate warning message for the user; the unit would continue to function and does not shut down immediately, thus, the treatment could be stopped in a controlled manner, if needed.In the reported event, the user continued the procedure for about 12 minutes and performed several fluoros and acquisitions.Afterwards the system was not no longer used.The user performed a power cycle 30 minutes later.However, the message "tube hot, have a break" was displayed again following the start-up.It was reported that the customer discovered water loss at the x-ray tube cooling unit in the morning of the next day.The on-site service intervention revealed that the filter strainer was leaking due to the sealing ring missing on the filter unit.The defective filter strainer was replaced on site.It could not be determined why the sealing ring was missing.It is assumed this was caused by improper workmanship during mounting.No similar occurrences have been reported from the field.To resolve the issue, the affected filter strainer was replaced as part of service activity.A possible general error that would require corrective measures of the installed base could not be determined by the investigation.

• Brand Name: ARTIS ZEEGO III
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 -or-; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234197
• MDR Report Key: 17509891
• MDR Text Key: 320884682
• Report Number: 3004977335-2023-00087
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10502505
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1