MAUDE Adverse Event Report: SOPHYSA PRESSIO® 2 ICP MONITOR

Model Number	PSO-4000
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending more information to perform a batch review and awaiting the return of the monitor to start device analysis.
Event or Problem Description
Pressio2 monitor will not shut down.It restart every time they try to shunt down.They have tried empty the batterie and reload it again, but the same problem occur.The monitor is less than 2 years old.
Event or Problem Description
Pressio2 monitor will not shut down.It restart every time they try to shunt down.They have tried empty the batterie and reload it again, but the same problem occur.The monitor is less than 2 years old.

• Brand Name: PRESSIO® 2 ICP MONITOR
• Common Device Name: ICP MONITOR
• Manufacturer (Section D): SOPHYSA; 5 rue guy môquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopôle temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy môquet; orsay, 91400 ; FR 91400
• MDR Report Key: 22173713
• Report Number: 3001587388-2025-00048
• Device Sequence Number: 9382879
• Product Code: GWM
• UDI-Device Identifier: 03760124132076
• UDI-Public: (01)03760124132076(11)220822
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K162108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: PSO-4000
• Device Catalogue Number: PSO-4000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown