MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. MEVATRON M2/PRIMUS MID-ENERGY; ACCELERATOR, LINEAR, MEDICAL

Model Number 1940035

Device Problems Unintended Collision (1429); Unintended Movement (3026)

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

Event Date 09/21/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens' investigation is ongoing and a supplemental report will be submitted upon completion.

Event Description

The customer notified siemens on september 26, 2016 that during a patient treatment the gantry movement started by itself.It was reported that after the execution of the first group of fields the customer went into the bunker to move the table from 90° to 0°.In that time the customer saw the gantry rotate in the clockwise direction from 0° (or just before 0) to the next position, which was 85°.A collision between the accessory holder of the mlc (attached to the gantry) and the table is reported however the gantry movement stopped by itself when it reached 85°.There is no report of injury or mistreatment to the patient.This reported event occurred in (b)(6).

• Brand Name: MEVATRON M2/PRIMUS MID-ENERGY
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; radiation oncology; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; radiation oncology; 4040 nelson avenue (closed); concord CA 94520
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mail stop: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 6057494
• MDR Text Key: 58770782
• Report Number: 2240869-2016-55948
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K993425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1940035
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2016
• 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
• Treatment: G31 V7 MOTHERBOARD: P/N 10652424, SN (B)(4, REV 01