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

Model Number 04504200

Device Problems Use of Device Problem (1670); 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.

• 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
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• 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
• Date Manufacturer Received: 04/20/2024
• 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