MAUDE Adverse Event Report: HITACHI LTD, HEALTHCARE BUSINESS UNIT MHI-TM2000 LINEAR ACCELERATOR SYSTEM/ VERO(TM); MEDICAL LINEAR ACCELERATOR

Model Number MHI-TM2000

Device Problems Computer Software Problem (1112); Device Issue (2379); Application Program Problem (2880); Device Operational Issue (2914); Programming Issue (3014)

Patient Problems Patient Problem/Medical Problem (2688); Radiation Exposure, Unintended (3164)

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

Hitachi investigated the event and duplicated the error condition in the factory.Due to system controller software anomaly, the couch of verotm/mhi-tm2000 may not move and patient position may not be corrected if all conditions described below are met: (1) calculate the patient positional deviation with exactrac, and press the [c-aut] button to move the couch in order to correct the patient positional deviation.(2) in order to acquire image, press the [x-ray] button within 1 second, after moving the couch.(this action is the likely reason that the couch did not move as directed.) (3) even if the patient positional deviation exceed the allowance value in the image registration of exactrac , the [c-aut] button do not blink (because the couch do not move, the patient positional is not corrected.) (4) press [skip] button to start treatment without verification.(operation that deviates from the normal instructions for use).

Event Description

One of our customers in (b)(6) reported an adverse event to the local distributor on (b)(6) 2017.The distributor notified hitachi on (b)(6) 2017.According to the explanation provided by the customer, we understand that following happened: 1.Patient was positioned with exactrac stereo x-ray normally.2.The therapist pressed the [x-ray] button to verify the position of the patient.3.The therapist tried to move the couch because there was a deviation from the target position, but the couch did not move.4.The therapist did not notice that couch did not move and that the ptv(planning target volume) was not in beam isocenter.The therapist proceeded to apply treatment.5.After the therapists applied several treatment beams they noticed that exactrac showed a deviation of the patient position.6.The therapist performed positioning again and continued the remaining treatment based on the therapist's medical judgment.

• Brand Name: MHI-TM2000 LINEAR ACCELERATOR SYSTEM/ VERO(TM)
• Type of Device: MEDICAL LINEAR ACCELERATOR
• Manufacturer (Section D): HITACHI LTD, HEALTHCARE BUSINESS UNIT; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer (Section G): HITACHI LTD. HEALTHCARE BUSINESS UNIT; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 27708 04; JA 2770804
• Manufacturer Contact: doug thistlethwaite ; 1959 summit commerce park; twinsburg, OH 44087 ; 3304251313
• MDR Report Key: 7060955
• MDR Text Key: 93698856
• Report Number: 8030405-2017-00003
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K152867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: MHI-TM2000
• Device Catalogue Number: 46300
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2012
• 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
• Patient Outcome(s): Other
• Patient Age: 62 YR