MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTISTE MV; ACCELERATOR, LINEAR, MEDICAL

Model Number 8139789

Device Problem Calibration Problem (2890)

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

Event Date 01/11/2022

Event Type  malfunction  

Event Description

It was reported to siemens by the siemens service engineer that they were sent to the customer facility to replace a malfunctioning waveguide.After replacement of the waveguide, the service engineer observed that the machine softpots were turned in a way that instead of a 300mu/min dose rate, a dose rate of 360mu/min was being released.After dosimetry calibration of the system by the siemens service engineer, the customer also performed an absolute dosimetry calibration.It was observed that the customer's approach and procedure to perform an absolute dosimetry calibration is not in accordance with siemens' recommendations.Based on the customer's calibration, it is assumed that the dose applied for 6mv is 20% too high and 10% too high for 10mv.It cannot be excluded that patients have been treated by the customer under these conditions received a 20% higher dose than prescribed and recorded in the treatment records.It is unknown to siemens how many patients were treated with a higher dose and for how long the customer's incorrect calibration had been used.Although no mistreatment or injury to patients, staff or service has been reported by the customer, the potential mistreatment risk to patients treated with the incorrect total dose, in a worst-case scenario, has a deviation of 20% for 6mv.The reported event occurred in turkey.

Manufacturer Narrative

The event was reported by a siemens field service engineer.Siemens has conducted a detailed technical investigation of the reported event.The root cause is that the customer used a non-siemens approved calibration method.The system instructions for use (ifu) in the physics primer section (t2-000.621.28.05.02, page 17) states the following: "monitor 1 is calibrated to the absolute dose which is usually set at 1cgy/mu for a 10cm x 10cm field size at the appropriate energy depth of dmax (depth of maximum ionization) and at the standard source-to-surface distance (ssd).Note: dose output and dose rate calibration are accomplished by the site physicist in the research mode of the b-softpot page".The customer is responsible for the correct calibration of the system.No mistreatment or injury of a person has been reported by the customer.If additional information becomes available regarding this event, siemens will submit a supplemental report.

• Brand Name: ARTISTE MV
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486484
• MDR Report Key: 13333885
• MDR Text Key: 295410322
• Report Number: 3002466018-2022-12194
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K072485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 01/24/2022

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: 8139789
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1