MAUDE Adverse Event Report: SOPHYSA SOPHYSA; PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL WITH BOLT

Model Number	PSO-PBT
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The physician reported a difference between icp values and displayed amplitude on the monitor; no health consequences reported on the patient.
Additional Manufacturer Narrative
Device was returned for analysis on 03/07/2022.Aspect control: the device returned in dry conditions in its original pack.Presence of blood marks on cone and pa tube.The rest of the device was relatively clean.Functional control : when first connected (in return state), the displayed values of temperature and pressure are stable.When simulated in testing, the sensor reacts normally.When tested in a water column under different pressure values, the sensor is stable, for 24 hours.Conclusion: in its returned state, the device is within specifications and the reported problem cannot be reproduced nor confirmed.

• Brand Name: SOPHYSA
• Common Device Name: PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL WITH BOLT
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; temis; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer Contact: marion prudhomme ; temis; rue sophie germain; besançon, 25000 ; FR 25000
• MDR Report Key: 13939429
• Report Number: 3001587388-2022-22092
• Device Sequence Number: 14650643
• Product Code: GWM
• UDI-Device Identifier: 03760124130768
• UDI-Public: (01)03760124130768(11)210817(17)260801
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K162108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/28/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2026
• Device Model Number: PSO-PBT
• Device Catalogue Number: PSO-PBT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Female