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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION PROSOUND F75

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FUJIFILM HEALTHCARE CORPORATION PROSOUND F75 Back to Search Results
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.
 
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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 Key14287230
MDR Text Key291374343
Report Number1528028-2022-00021
Device Sequence Number1
Product Code IYN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date04/06/2022
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/05/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age65 YR
Patient SexMale
Patient Weight56 KG
Patient RaceBlack Or African American
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