MAUDE Adverse Event Report: HITACHI, LTD., HEALTHCARE HITACHI WORKS PROBEAT-V; PROTON BEAM THERAPY SYSTEM

Model Number PROBEAT-V

Device Problems Use of Incorrect Control/Treatment Settings (1126); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2017

Event Type  malfunction  

Event Description

A parameter in the positioning image analysis system (pias) for isocenter position #1 in treatment room 2 was mistakenly changed during the software modification work on (b)(6) 2016.A service and maintenance engineer discovered the mis-setting of the parameter on (b)(6) 2017, and it was corrected immediately.According to the treatment record after (b)(6) 2016, one patient was found to receive treatments around the shoulder at isocenter position #1.The fourteen fractions out of twenty-five were applied to the patient under the faulty condition starting from (b)(6) 2016.The incorrect parameter could have affected the patient positioning accuracy.As a result of investigation, the amount of deviation is estimated in the range of 0.24cm to 1.36cm, varying by each fraction.No adverse event for the patient has been reported.This issue has been resolved and the system is currently working correctly.

• Brand Name: PROBEAT-V
• Type of Device: PROTON BEAM THERAPY SYSTEM
• Manufacturer (Section D): HITACHI, LTD., HEALTHCARE HITACHI WORKS; 3-1-1 saiwai-cho; hitachi-shi, ibaraki 317-8 511; JA 317-8511
• Manufacturer (Section G): HITACHI, LTD., HEALTHCARE HITACHI WORKS; 3-1-1 saiwai-cho; hitachi-shi, ibaraki 317-8 511; JA 317-8511
• Manufacturer Contact: mikimoto takamatsu ; 50 prospect ave; north tarrytown, NY 10591 ; 9145246636
• MDR Report Key: 6398200
• MDR Text Key: 70017827
• Report Number: 3003993895-2017-00001
• Device Sequence Number: 1
• Product Code: LHN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PROBEAT-V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 03/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• 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