MAUDE Adverse Event Report: SOPHYSA PRESSIO ICP MONITORING KIT, PARENCHYMAL TUNNELLING; ICP MONITORING CATHETER

Model Number PSO-PT

Device Problems Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2023

Event Type  malfunction  

Event Description

After approx 24 hours an error code e001 came up on the monitor.The hospital staff tried changing the console and cables all to no effect.The catheter was removed and a new one inserted.

Manufacturer Narrative

Error e001 confirmed on monitor.Abnormal extension of the pa tube over approximately 2 cm which caused the cable to break in the pa tube.User error confirmed.

Event Description

After approx 24 hours an error code e001 came up on the monitor.The hospital staff tried changing the console and cables all to no effect.The catheter was removed and a new one inserted.

• Brand Name: PRESSIO ICP MONITORING KIT, PARENCHYMAL TUNNELLING
• Type of Device: ICP MONITORING CATHETER
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopôle temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: marion prudhomme ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 17817607
• MDR Text Key: 324255928
• Report Number: 3001587388-2023-23419
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 03760124130782
• UDI-Public: (01)03760124130782(11)221014(17)270901
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K162108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PSO-PT
• Device Catalogue Number: PSO-PT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other