MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ONCOR IMPRESSION PLUS; MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM

Model Number 5857912

Device Problems Self-Activation or Keying (1557); Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 08/25/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation of the reported event is on-going.Emergency stop buttons are available on the unit to stop all system movement.A supplemental report will be submitted if additional information becomes available this report was submitted september 21, 2016.

Event Description

The customer had a pause entered between the second superior anterior oblique (sao) field and the posterior-anterior (pa) field to prevent automatic gantry rotation in order to avoid any collision with patient and table.The patient was due for a film of the pa field.Due to risk of collision the therapists present at the treatment disabled the auto deploy on the flat panel.When the therapists downloaded the two fields there was a stop/pause on the pa field as usual.When the treatment of the second sao field was completed, the therapists noticed that the gantry started rotating on its own, even with a pause still being displayed.The therapists hit the rad off button and the button to open the door before the gantry hit the patient's arms, the vac-loc and the table.The gantry movement was stopped.It is assumed that having a film in the session disabled the pause that had been entered earlier, however, the pause was still displayed due the auto-deploy being disabled.There are no injuries attributed to the event.

• Brand Name: ONCOR IMPRESSION PLUS
• Type of Device: MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HELTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 5966204
• MDR Text Key: 55693490
• Report Number: 2240869-2016-52796
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other