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

Device Problems Unintended System Motion (1430); Self-Activation or Keying (1557)

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

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens became aware of the reported issue on october 3, 2016 and the investigation in on-going.A supplemental report will be submitted upon completion.This information has been requested and has not been received, to date.Should the information become available a supplemental report will be submitted at the required regulatory timelines.

Event Description

The customer informed siemens on october 3, 2016 that during manual positioning of a patient in the treatment room, either the table locked by itself or it changed vertical high speed to low by itself.Reportedly, on (b)(6) 2016, the patient was manually positioned on the table.The gantry position was set at the treatment console by pushing f12, alt enable and the gantry moved to position.However, the table made a longitudinal movement of 20 cm from the gantry at the same time of the gantry movement.It was also reported that on (b)(6) 2016, the patient was manually positioned on the table.The gantry position was set at the treatment console by pushing f12, alt enable to move to position.The table position was also set at the treatment console by pushing f12, alt enable to iso 310' position.However, movement of the gantry and table occurred at the same time with the table making a longitudinal movement of 8.5 cm from the gantry.There are no reports of injury or mistreatment to a patient.This reported issue occurred in (b)(6).

• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; medical solutions; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; medical solutions; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mail stop: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 6074723
• MDR Text Key: 59460511
• Report Number: 2240869-2016-56625
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/03/2016

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
• Initial Date Manufacturer Received: 10/03/2016
• Initial Date FDA Received: 11/02/2016
• 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