MAUDE Adverse Event Report: HITACHI, LTD., HEALTCARE HITACHI WORKS HYBEAT; PARTICLE BEAM THERAPY SYSTEM

Model Number HYBEAT

Device Problems Application Program Problem: Parameter Calculation Error (1449); Failure to Read Input Signal (1581); Malposition of Device (2616)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

As the result of the investigation, it is confirmed that a position discrepancy occurs under the two conditions below, between the plan based on ct and the dr image taken at the pbts, when using the pias 3d-2d matching mode for the patient positioning.Slice deficiency occurs in ct data due to the data receiving failure.The deficient count out of the ct slices results in the position discrepancy by the length multiplying the deficient count by the slice pitch.Total count of ct slices is odd.This results in the position discrepancy of the half length of the slice pitch.

Event Description

On (b)(6) 2019, at a hospital in (b)(6), abnormal images for positioning in the particle beam therapy system (pbts) were found prior to the treatment.The images were loaded from the ct image database in pias (positioning image analysis system) installed in the pbts.The images were unusual, thus they were not used, then the treatment was carried out rightly using the other plan instead.On (b)(6)2019, as per the investigation, it was found that the slice deficiency in ct data which registered in the pias had occurred once in a while, and it had caused the image abnormality for the positioning.And also, it had brought the discrepancy between the target position in the plan and that in the real beam position.The retrospective investigation was started for all the patients received the treatments since (b)(6) 2018, the treatments began at that time.On (b)(6) 2019, as a result, some patients were found to be received the treatments with the position discrepancy due to the ct slice deficiency.Particularly, one of the patients was received the treatment with the discrepancy of 3.2 mm.Two times of the treatment with 3.2 mm discrepancy were conducted out of total sixteen treatments.No adverse event for all the patient has been reported.Supplemental: reason for submission- delay despite the first submission was carried out on (b)(6) 2019.

• Brand Name: HYBEAT
• Type of Device: PARTICLE BEAM THERAPY SYSTEM
• Manufacturer (Section D): HITACHI, LTD., HEALTCARE HITACHI WORKS; 3-1-1 saiwai-cho; hitachi-shi, ibaraki 317-8 511; JA 317-8511
• Manufacturer Contact: mikimoto takamatsu ; 50 prospect avenue; tarrytown; 5072618534
• MDR Report Key: 8512837
• MDR Text Key: 152802227
• Report Number: 3003993895-2019-00001
• Device Sequence Number: 1
• Product Code: LHN
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 03/18/2019

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: HYBEAT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2018
• 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