MAUDE Adverse Event Report: ION RT LTD., VISION RT LIMITED GATERT; GATERT PATIENT POSITIONING SYSTEM

Model Number GATERT

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 01/07/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation of the issue is still in progress.,.

Event Description

When using phase-based gating in gatert, the expected behavior is that the beam is enabled in the interval specified by the user between phase tags which have been correctly identified.However, it has been observed that irregular breathing may cause the software to incorrectly assign phase tags to the breathing signal and thus, under specific conditions, gating may occur at incorrect portions of the breathing cycle.Therefore, the actual behavior is that the beam may be enabled in the interval specified by the user between phase tags which, from time to time, may be incorrectly identified.This would result in enabling the beam for phases of the breathing cycle not defined b y the user.It should be noted that the actual beam status is correctly displayed on the software screen.The existing "abnormal breathing detection" function detects abnormal breathing, which in turn prevents the beam to be enabled during such circumstances.Additionally, the "limiting regions" function further reduces the likelihood that the potential issue may have a clinical impact.The use of these functions (which are not present in all devices in the field ) is already described in the current gatert user guide.There are no reports of any patient or user harm related to this issue.The issue was identified during testing, and not in clinical use of the device.There are no reports of the issue having occurred in clinical use.

• Brand Name: GATERT
• Type of Device: GATERT PATIENT POSITIONING SYSTEM
• Manufacturer (Section D): ION RT LTD., VISION RT LIMITED; london ; UK
• Manufacturer Contact: francesco sapia, manager ; dove house, arcadia avenue; london N3 2J-U ; UK N3 2JU ; 833257840
• MDR Report Key: 5433871
• MDR Text Key: 38490662
• Report Number: 3004832819-2016-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K072171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/05/2016

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
• Device Model Number: GATERT
• Device Catalogue Number: GATERT
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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