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

Model Number 95478

Device Problem Unintended Movement (3026)

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

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Siemens completed a technical investigation of the reported event.The current design of the txt-table allows a motion stop signal to be generated after an angular movement between 0,5 degrees 3,5 degrees.The complaint behavior is within the required range given by design.To assure a correct braking force of the magnet brakes used on the isocenter and column axis the brake itself will be maintained yearly.If the braking force is to low (<350nm) it should be checked in the area where the magnet brakes are mounted to determine if the area is dusty.If the area is dusty, it should be cleaned.The table should be rotated to several positions so that all sections of the brake contact surfaces are clean.If the area is not dusty, the air gap should be readjusted (the correct range is 0,1 - 0,6mm).If the braking force is still too low, the whole magnetic brake kit has to be replaced.Additional action is not warranted at this time.The reported event occurred in (b)(6).

Event Description

It was initially reported to siemens on (b)(6) 2018, 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 and did not result in patient injury.This event was reported to the fda in manufacturer report number 3002466018-2018-61191 on 04-jan-2019.During the investigation of the event by siemens, a second potential issue was identified on (b)(6) 2019 in relation to the above event.The movement of the table was in the column axis and not in the isocentric axis.The unnoticed movement of the table in the column axis could lead to a potentially hazardous situation.If the deviation between the actual value and the planned value is smaller than 2 degrees, the control console will not identify the mismatch.In a worst case scenario the patient might be mistreated by a dose being applied to the wrong location (>10mm).This issue could also lead to severe patient injury.

• Brand Name: ONCOR IMPRESSION PLUS
• 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: 8279119
• MDR Text Key: 136146274
• Report Number: 3002466018-2019-61187
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 95478
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/24/2019
• Event Location: Hospital
• Date Manufacturer Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1