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

Model Number 5857912

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 10/12/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens' investigation has shown that the system works as specified.The minimum distance of the flatpanel positioner during gantry rotation was reduced intentionally by a software update.It is described in the digital linear accelerator operator manual that the user must always verify the clearance of rotating parts in a treatment plan prior to patient treatment in order to avoid collision and serious injury.Considering this, no corrective action is initiated.

Event Description

Siemens became aware on (b)(6) 2017 of a change in system behavior that was experienced during an onsite application training.It was reported that the flatpanel positioner no longer retracts to 160cm before the gantry rotates.Depending on patient position as well as the user being aware of the change in system behavior, a collision is possible with the flatpanel positioner and the patient.However, there is no report of injury.(b)(6).

• Brand Name: ONCOR IMPRESSION PLUS
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; advanced therapy; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; advanced therapy; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mc: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 7018542
• MDR Text Key: 92677773
• Report Number: 3002466018-2017-01015
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/10/2017,10/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5857912
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2017
• Distributor Facility Aware Date: 10/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2017
• Date Manufacturer Received: 10/15/2017
• 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