MAUDE Adverse Event Report: HITACHI AMERICA, LTD., HEALTHCARE DIVISION G2; SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL

Device Problems Inaccurate Delivery (2339); Device Operates Differently Than Expected (2913)

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

Event Date 12/06/2016

Event Type  malfunction  

Event Description

There were alarms and pauses while delivering the treatments fields on g2.The treatment was stopped on g2 and the machine was reviewed for diagnosis and repair.The problem was found to be the switch for the second scatter.The switch was causing the beam to be delivered at an angle rather than flat.

• Brand Name: G2
• Type of Device: SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL
• Manufacturer (Section D): HITACHI AMERICA, LTD., HEALTHCARE DIVISION; 50 prospect avenue; tarrytown NY 10591
• MDR Report Key: 6303571
• MDR Text Key: 66586439
• Report Number: 6303571
• Device Sequence Number: 1
• Product Code: LHN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2016,01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2016
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1