MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ONCOR IMPRESSION PLUS SYSTEM; ACCELERATOR, LINEAR, MEDICAL

Model Number 05857912

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 10/27/2014

Event Type  malfunction  

Event Description

Siemens was notified on (b)(6) 2014 that when finishing a pt treatment, the customer noticed that the table had moved to the right, facing the gantry, which means there was an unintended lateral movement during treatment.There is no report of an injury to the pt.This reported issue occurred in (b)(6).

Manufacturer Narrative

Siemens was informed of the reported event on (b)(6) 2014 and this mdr is being mailed on november 26, 2014.The investigation is ongoing and a supplemental report will be submitted upon completion.

• Brand Name: ONCOR IMPRESSION PLUS SYSTEM
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.
• Manufacturer Contact: marlynne galloway ; 51 valley stream parkway; ms - d02; malvern, PA 19355 ; 6102195361
• MDR Report Key: 4329275
• MDR Text Key: 16179427
• Report Number: 2910081-2014-08581
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/27/2014

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: 05857912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2014
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TXT TABLE - MATERIAL NO. 07346534, SN # (B)(4); SW VERSION 9.2.18