MAUDE Adverse Event Report: ECHOSENS SA FIBROSCAN; ULTRASONIC PULSED ECHO IMAGING SYSTEM

Model Number	530
Medical Device Problem Codes	Overheating of Device (1437); Battery Problem (2885); Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Between two examinations.Staff members reported sparks and a burning smell.The device was immediately removed from the room and taken toward an open area.While it was being moved, the machine caught fire.The fire self-extinguished with in a few seconds.No harm occured to any person.

• Brand Name: FIBROSCAN
• Common Device Name: ULTRASONIC PULSED ECHO IMAGING SYSTEM
• Manufacturer (Section D): ECHOSENS SA; 6 rue ferrus; paris, 75014 ; FR 75014
• Manufacturer (Section G): ECHOSENS CRETEIL; 5 rue jean lemoine; creteil val-de-marne, 94000 ; FR 94000
• Manufacturer Contact: fanny patoureaux ; 6 rue ferrus; paris, 75014 ; FR 75014
• MDR Report Key: 24291612
• Report Number: 3010258456-2026-00001
• Device Sequence Number: 18474693
• Product Code: IYO
• UDI-Device Identifier: 03662264001185
• UDI-Public: 03662264001185
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: K223902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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
• Operator of Device: Health Professional
• Device Model Number: 530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown