MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH PRIMUS HI; ACCELERATOR, LINEAR, MEDICAL

Model Number 4504200

Device Problem Use of Incorrect Control/Treatment Settings (1126)

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

Event Date 01/16/2022

Event Type  malfunction  

Event Description

It was reported to siemens by the siemens service engineer that the customer (user) had bypassed the interlocks asserted by the system due to detected problems with the dosimetry system.The customer used "research" mode with only temperature latched to treat electron patients.When the system is in "research" mode, not all interlocks force the system to stop (e.G., radiation).The number of patients treated in this manner was not provided to siemens.Although no patient mistreatment or injury of a patient or user have been reported, this kind of user error could lead to severe radiation injury to the patient or user.The reported event occurred in (b)(6).

Manufacturer Narrative

Udi is not available due to age of the system.Initial reporter is a siemens employee.A contact name and contact information for the facility were not provided to siemens.Device evaluated by mfr: siemens completed the investigation of the reported event.The root cause of the event is use error.The customer (user) inentionaly bypassed the interlocks and used "research" mode to treat patient(s).During the investigation the siemens customer service engineer (cse) found that there was a drift between temperature 1 and temperature 2, occurring after 4 to fi house of x-ray treatments.The customer reported that the workaround was to treat the electron patients, with no need to bypass interlocks.Due to the dose chambers used (open for electrons/closed to photons) there is a dependency on the temperature and pressure (electrons and no photons).It is assumed that the defective g42 pcb caused the interlock #04 temp/pressure*.The asserted interlock il4 only has influence on electron dosimetry.The cse replaced the g42 pcb and restored the system.It is clearly stated in the system instructions for use (e.G., t2-000.621.33.05.02, chapter 2, product-specific safety advice, page 86) that "patients are to be treated in manual treatment mode or r&v mode only.Under no circumstances should a patient be treated in either service or research mode.The reason for this safety statement is that in "research" mode the sw interlocks are detected by the system, but the detection of the interlocks does not force the system to stop immediately (e.G., the radiation).This kind of user error could lead to severe injury to the patient.

• Brand Name: PRIMUS HI
• 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: 13395607
• MDR Text Key: 295703455
• Report Number: 3002466018-2022-13093
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K993425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4504200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• 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