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

Model Number 7360717

Device Problems Use of Incorrect Control/Treatment Settings (1126); No Apparent Adverse Event (3189)

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

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Siemens has initiated an investigation of the reported event.A root cause has not yet been identified but at this time, it is known that the user intentionally disabled the automatic motion protection (amp).A supplemental report will be filed upon the completion of the investigation.The reported event occurred in (b)(6): (b)(6).

Event Description

It was reported to siemens that during maintenance of the oncor expression system, the customer service engineer discovered that the automatic motion protection (amp) had been deliberately disabled by the customer.Though there was no report of patient injury, mistreatment, or interruption of patient treatment, the amp algorithm predicts potential collision during user-programmed auto-sequences of treatment fields.If the amp is disabled, the control console cannot predict potential collisions.This event is being conservatively reported because if the amp is disabled, there is a potential for the automated field sequence resulting in a collision of the system with the patient, resulting in serious injury.

Manufacturer Narrative

Exemption number: e2017019.Siemens healthineers malvern usa (importer) is submitting the report on behalf of siemens healthcare gmbh, kemnath (manufacturer).Siemens has completed the investigation of the reported event.This event arose from the potential of patient injury due to the user intentionally disabling the system automatic motion protection (amp).If the amp is disabled, the automated field sequence may result in a collision of the system with the patient.The reason for the user disabling the system (amp) is unknown.Though there is no allegation of system malfunction, further understanding of the how and why the system amp would have been disabled was investigated.The amp can be deactivated on the control console in a password-protected service mode by a siemens service technician.The implementation of such an option (enable/ disable) is needed for service purposes.With a special training the customer (physicist) or "user" can also obtain access to this layer of the service mode with the intention to configure and to parameterize the amp functionality in order to be able to treat patients as successfully as possible (e.G.Where special accessories are recommended).If the movement protection is disabled, the user will be notified by the system in the record and verify (r&v) mode.Therefore, if the following prerequisites are fulfilled before treating a patient with disabled amp the risk /benefit ratio of the system is still considered acceptable per treatment delivery system ra 10652762 ega 701 03 p.297: the user is programming an autosequenced treatment considering the used accessories and the necessary clearance between gantry and patient.The programed autosequence does not have a potential for a collision of the system with the patient.The user is performing a dry run prior to the patient´s treatment as recommended in the user manual.The user is monitoring the patient and the system during the treatment.If the user is monitoring the system, he shall stop the automatic motion of the system by pressing one of the motion stop buttons in case of a potential collision.

• Brand Name: ONCOR EXPRESSION
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• MDR Report Key: 8113089
• MDR Text Key: 129344888
• Report Number: 3002466018-2018-55457
• 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: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7360717
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2018
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1