MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ONCOR IMPRESSION PLUS; ACCELERATOR, LINEAR, MEDICAL

Model Number 5857912

Device Problems Unintended Collision (1429); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Siemens has initiated a technical investigation of the reported event.A root cause has not yet been identified.A supplemental report will be filed upon the completion of the investigation.(b)(6).

Event Description

It was reported to siemens that during treatment of a patient with the oncor impression plus system, the flat panel positioner (fpp) touched the patient treatment table while the gantry was rotating.The user further reported that the touch-guard of the fpp is not sensitive enough and the setting sensitivity of the fpp collision interlock (il) is not sufficient.The treatment was completed.This event did not result in patient injury, however, if the user is not aware of the reported system behavior as described in the user manual and does not perform a "dry run" prior to the treatment of a patient, collision of the system with the patient could occur and result in severe bodily injury.

Manufacturer Narrative

Siemens completed an investigation of the reported event.The functionality of the collision protection system at the customer facility has been checked.No malfunction could be identified.The force applied from any direction is below the value specified by the risk assessment "evaluation of the patient hazard due to collision with fpp".The motion stop was not set because the applied force at the collision was most probably under the threshold.There was an unfortunate correlation between the weak column brakes which allowed the eccentric table movement without causing the motion stop interlock to drop.Further action is not warranted at this time.

• Brand Name: ONCOR IMPRESSION PLUS
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• MDR Report Key: 8217930
• MDR Text Key: 132975230
• Report Number: 3002466018-2018-61191
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K060226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/04/2019,12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5857912
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2019
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1