MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG PRIMUS HI; ACCELERATOR, LINEAR, MEDICAL

Model Number 04504200

Device Problems Use of Device Problem (1670); Calibration Problem (2890); Insufficient Information (3190)

Patient Problems Radiation Burn (1755); Ulcer (2274)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

The concerned unit is serviced by a third party.Dose and beam profile were checked and found to be normal.No system malfunction has been reported.Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed if additional information becomes available.

Event Description

Siemens became aware of an incident that occurred while operating the primus hi unit.The user called siemens customer service on (b)(6) 2024, to report five patients that had experienced radiation damage after being irradiated with 6mev therapy in (b)(6) 2023.The radiation damage was described by the user as induced skin ulcers.On (b)(6) 2024, additional information was provided that one patient required a skin grafting surgery.

Manufacturer Narrative

In total the user reported five (5) patients that experienced radiation damage.These patient treatments took place between (b)(6) 2023.However, only one patient required skin graft following the radiation treatment.The customer did not provide photos of the skin damages as requested by siemens.Typically, these skin lesions are characterized by redness, swelling and blisters.According to the information provided by the customer, the machine was repaired twice during this time period (10/30/2023-11/30/2023).1.) (b)(6), 2023, system reinstallation after console battery replacement with dose rate optimization.2.) november 28, 2023, the x-ray ionization chamber and g42 dose circuit board were replaced as no x-rays were detected.The investigation conducted by siemens showed that the medical facility continued to use the machine for patient treatments without performing the beam profile and dosing calibration/check after the repair had been completed.Quality assurance history has been requested but was not provided by the customer.The user manual clearly states the machine must evaluated by a physicist following service interventions.No device malfunction could be determined.The dosimetry calibration is under user¿s responsibility.The customer performed dosimetry and beam profile check on april 9, 2024, and it was found to be within the normal ranges.As no detailed data from the concerned system (logfiles, service history etc.) as well as no detailed treatment data were available, further investigation was not possible.There has no product design deficiency been alleged.

• Brand Name: PRIMUS HI
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; doris-ruppenstein-str. 4; erlangen 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; doris-ruppenstein-str. 4; erlangen 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 19163716
• MDR Text Key: 340825859
• Report Number: 3006894636-2024-00002
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K993425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04504200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 05/23/2024
• 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