MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM

Model Number N/A

Device Problems No Display/Image (1183); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, fujifilm healthcare americas corporation became aware of an event that occurred on (b)(6) 2022.Involving the prosound f75 diagnostic ultrasound system.It was reported that the system powered off during a procedure and took approximately 30 minutes to power back on.No additional information was provided.There is no death or serious injury reported with this event.As such, this report is being submitted in an abundance of caution.

• Brand Name: PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
• 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: 15154105
• MDR Text Key: 297227890
• Report Number: 1528028-2022-00058
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• 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?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/05/2022
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1