MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION PROSOUND F-75

Model Number U7F0443

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 08/05/2021

Event Type  Injury  

Manufacturer Narrative

Fujifilm received a complaint notification from olympus on 8/5/2021 regarding the prosound f75 ultrasound (u7f0443).The site reported that it was taking 10-15 minutes for the system to boot up and when it finally did, the image is black.They attempted to reboot the system and the issue persisted.Fujifilm spoke with (b)(6) on 8/5/2021 and confirmed that the patient was under anesthesia when the procedure was cancelled.Fujifilm made multiple attempts at following up with (b)(6) and other techs on site to gather more information about the procedure.No further details were provided.The field service engineer was able to reproduce the error.He replaced the hard drive and the system immediately booted without issue and image displayed as intended.Fujifilm will be sending the hard drive to the manufacturer for investigation.

Event Description

On august 5, 2021 fujifilm healthcare americas received a report of an aborted procedure.The site was using the f75 ultrasound u7f0443.

Manufacturer Narrative

The investigation concluded that the control board failure was a random component failure that did not require remedial action.During a retrospective review, it was discovered that the investigation was ongoing at the time of the initial mdr, and the investigation results had not been reported to fda.As such, a supplemental mdr is being submitted at this time.

• Brand Name: PROSOUND F-75
• Type of Device: PROSOUND F-75
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer (Section G): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer Contact: kan tsushima ; 2-1 shintoyofuta; kashiwa-shi, chiba-ken, OH 277-0-804 ; JA 277-0804 ; 3304251313
• MDR Report Key: 12365245
• MDR Text Key: 268057362
• Report Number: 8030405-2021-00008
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123828
• 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,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: U7F0443
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2013
• 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 Sex: Prefer Not To Disclose