MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION PROSOUND F75

Model Number N/A

Device Problem Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

On april 06, 2022, fujifilm healthcare americas corporation received a complaint regarding the prosound f75.The site reported that the device shut down during a biopsy procedure.The trouble-shooting steps were performed to fix the issue to get the system running properly but were unsuccessful.The procedure was aborted and rescheduled at another hospital.There is no death or serious injury associated with this event.As such, this report is being submitted in an abundance of caution.

• Brand Name: PROSOUND F75
• Type of Device: PROSOUND F75
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• MDR Report Key: 14287230
• MDR Text Key: 291374343
• Report Number: 1528028-2022-00021
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/04/2022

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: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/06/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 56 KG
• Patient Race: Black Or African American