MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ONCOR AVANT GARDE; ACCELERATOR, LINEAR, MEDICAL

Model Number 5863472

Device Problem Device Fell (4014)

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

Event Date 03/26/2022

Event Type  malfunction  

Manufacturer Narrative

Udi is unknown due to age of device.Initial reporter is a siemens employee.A contact name and contact information for the facility were not provided to siemens.Siemens initiated an investigation of the accessory holder related to the reported event.A root cause has not yet been determined.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported to siemens that during a service intervention (no patient involvement), an electron applicator was inserted into the accessory holder when the gantry was at 180° position.The gantry was rotated to 0° position, clockwise from 180° to 0°.During this movement the electron applicator fell out of the accessory holder onto the floor.The table was retracted at the time of the event, so no damage to the table occurred.The accessory holder was sent back for investigation by siemens.There was no report of injury due to the reported event.However; in a worst-case scenario, injury could occur due to falling objects.This report has been submitted with an abundance of caution.The reported event occurred in ireland.

Manufacturer Narrative

The technical investigation of the provided "accessory holder assy-h33" (part number 9839317) was completed with the following result: during test setup siemens was able to reproduce the reported situation: the interlock disappeared before the accessory was completely locked.However, this situation may only occur under certain circumstances.The accessory must be inserted very slowly and carefully to find the exact point, where the micro-switch triggers (withdraws) the interlock signal, but the accessory is not locked securely.Only under these circumstances - it is possible to remove the accessory despite the interlock being released.The analysis of the provided complaint part didn't reveal a general design issue, but an improper adjustment of the "full insertion switch".The system has been repaired by replacement of the complete accessory holder.To prevent any injury caused by unlocked accessories, a red warning label is placed on every accessory holder: "verify that all accessories are locked in place prior to treatment delivery".Furthermore, several warnings regarding correct mounting of accessories (in addition to the warning label at accessory holder itself) and clearance to patient can be found in the user documentation (print number t2-000.621.26.03.02) under section "2 safety".

• Brand Name: ONCOR AVANT GARDE
• 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 ; 4843234198
• MDR Report Key: 14100089
• MDR Text Key: 298728458
• Report Number: 3002466018-2022-22326
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K031764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5863472
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: No
• 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