MAUDE Adverse Event Report: HITACHI LTD, HEALTHCARE BUSINESS UNIT PROSOUND F-75

Model Number U7F0018

Device Problems Display Difficult to Read (1181); Poor Quality Image (1408)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2021

Event Type  Injury  

Manufacturer Narrative

Hitachi received a complaint notification from olympus on (b)(6) 2021 regarding the prosound f75 ultrasound (u7f0018).The site reported to olympus that they were completing a procedure on (b)(6) 2021 when they noticed very grainy images.The doctor was unable to make out clear visuals and the procedure was aborted.Hitachi called the site on (b)(6) 2021 for more information and confirmed that it was an egd/eus procedure.The patient was under anesthesia when the procedure was cancelled.Hitachi service worked with clinical applications and confirmed that the issue is not due to a malfunction within the ultrasound system, but rather due to changes in system presets.System presets are available for the customer to change without notifying hitachi.Hitachi does not know who or when the presets were changed.An applications specialist reloaded the customer's presets/settings and problem was resolved.

Event Description

On (b)(6) 2021 hitachi received a report of an aborted procedure.The site was using the f75 ultrasound u7f0018.

• Brand Name: PROSOUND F-75
• Type of Device: PROSOUND F-75
• Manufacturer (Section D): HITACHI LTD, HEALTHCARE BUSINESS UNIT; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 704; JA 277-0704
• Manufacturer (Section G): HITACHI LTD., HEALTHCARE BUSINESS UNIT; 2-1 shinotoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer Contact: leigh bryner ; 1959 summit commerce park; twinsburg, OH 44087 ; 3304251313
• MDR Report Key: 11850829
• MDR Text Key: 255937857
• Report Number: 8030405-2021-00006
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: U7F0018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2016
• 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: 76 YR