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 Consequences Or Impact To Patient (2199)

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation is on-going and a supplemental report will be submitted upon completion if further information becomes available.(b)(4).

Event Description

The customer notified siemens on (b)(6) 2017 that an error message appeared on rt therapist when the user attempted to do a table offset calculation with portal imaging.The error message stated that the user could not select the image for 3d offset calculation because "selection of multiple images is only allowed with orthogonal images of the same table position".The message instructed the user to "select an orthogonal image of the same table position with respect to the previously selected image".It is reported that it seems the vertical txt treatment table values differed by 2 mm between the acquisition of two orthogonal images, however, it is unknown if the table actually moved or if it is only a display issue.There is no report of injury or mistreatment to a patient.This reported issue occurred in (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: 7021807
• MDR Text Key: 92681308
• Report Number: 3002466018-2017-01245
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 11/10/2017,10/18/2017

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: 10/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2017
• Date Manufacturer Received: 10/18/2017
• 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