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

Model Number 5857912

Device Problem No Apparent Adverse Event (3189)

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

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Siemens has completed the "investigated" 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 ((b)(6)) 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.(b)(6).

Event Description

It was reported to siemens that during maintenance of the oncor impression plus system, the customer service engineer discovered 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.

• 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: 8135085
• MDR Text Key: 130050788
• Report Number: 3003202425-2018-57229
• 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: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/14/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2018
• Date Manufacturer Received: 11/14/2018
• 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: Reuse
• Patient Sequence Number: 1