MAUDE Adverse Event Report: HITACHI LTD, HEALTHCARE BUSINESS UNIT ECHELON OVAL; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number ECHELON OVAL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Missing Value Reason (3192)

Patient Problems Hearing Loss (1882); Patient Problem/Medical Problem (2688)

Event Date 08/08/2017

Event Type  Injury  

Manufacturer Narrative

The echelon oval is a 1.5 tesla horizontal field (cylindrical bore) mri system.Hitachi had no awareness of the patient's complaint before receiving the letter and has no evidence that the patient complained to the user facility at the time of the exam.Hitachi examined service or applications helpline calls and confirmed that no calls were received on or shortly after the event date reported by the insurance agency.After receiving the complaint notice, hitachi performed acoustic testing at the user facility but was not able to complete the testing due to inability to secure enough time from the customer.Test results that were achieved indicated a maximum average acoustic noise level of 110.7 db(a) and peak noise of 123 db.The average noise level measurements represents what the patient would experience without hearing protection.The user facility reports that they use a combination of earplugs (howard leight - nrr 33 db), and a magnacoustics headset - nrr 18 db.Therefore, with the available hearing protection, the perceived noise to the patient should be under 99 db(a) as specified in iec (b)(4) and present no direct risk of injury.No other patients reported excess noise at the user facility and based on the available evidence, hitachi does not believe the echelon oval malfunctioned and caused the reported hearing loss.

Event Description

Hitachi was informed by letter from a customer's insurance agency that a patient was scanned on the hitachi echelon oval mri system on or about (b)(6) 2017.The patient alleges that the machine was too loud during a procedure involving a mri of his shoulder, and that as a result, he suffered hearing loss.

• Brand Name: ECHELON OVAL
• Type of Device: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• 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 277-0 804; JA 277-0804
• Manufacturer Contact: douglas thistlethwaite ; 1959 summit commerce park; twinsburg, OH 44087 ; 3304251313
• MDR Report Key: 7518227
• MDR Text Key: 108391065
• Report Number: 8030405-2018-00002
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Radiologic Technologist
• Device Model Number: ECHELON OVAL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 76