MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AT-RO ONCOR IMPRESSION; ACCELERATOR, LINEAR, MEDICAL

Model Number 5857920

Device Problem Unintended Movement (3026)

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

Event Date 02/12/2017

Event Type  malfunction  

Manufacturer Narrative

A root cause of the issue has not been identified as the investigation is on-going.A supplemental report will be submitted if further information becomes available.

Event Description

The customer notified siemens on (b)(6) 2017 that the txt table top drops down for opproximately 4 cm during movement.No mistreatment or injury to a patient has been reported.This reported incident occurred in (b)(6).

Manufacturer Narrative

Investigation has shown that the reported system behavior occurred during patient positioning and not during treatment.The sporadic, vertical txt table movement was due to a defective relay with abnormal wear on the contacts.The relay was replaced and the system in functional.Per design an uncommanded vertical table motion is detected by the system after 2mm of table motion and triggers a motion stop interlock that immediately activates the magnetic brakes to stop the movement after 2 to 3cm, which is what occurred in this case.Therefore, no risk to the patient could be identified and the system behavior is considered to be not safety related.Considering this, no further corrective action is initiated.

• Brand Name: ONCOR IMPRESSION
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH AT-RO; medical solutions; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH AT-RO; medical solutions; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mail stop 65-1a; malvern, PA 19355 ; 6104486471
• MDR Report Key: 6395799
• MDR Text Key: 70008733
• Report Number: 2240869-2017-70863
• 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,Followup
• Report Date: 02/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5857920
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2017
• 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