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

Model Number PSO-PB

Device Problem Device Sensing Problem (2917)

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

Event Date 10/03/2023

Event Type  malfunction  

Event Description

Fibre no longer works error code e001, pic number on monitor 300.All sensors and monitors changed; error code persists.

Manufacturer Narrative

11/03/2023 analysis: opening the dongle shell shows that the micro-cable is broken under the electronic board, with part of it also trapped under the board.As the catheter had been operating normally for several days, excessive and abnormal traction during use beyond the authorized length undoubtedly caused the irreversible breakage observed.Conclusion: the return catheter is not compliant, and a break in the micro-cable on the electronic board is the cause of error e001 observed in use.

Event Description

Fibre no longer works with error code e001, icp number on monitor>300.All sensors and monitors changed but the error code persists.

• Brand Name: PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL WITH BOLT
• Type of Device: PSO-PB
• Manufacturer (Section D): SOPHYSA; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer Contact: marion prud'homme ; 5 rue guy môquet; 91400, ORSAY ; FR ORSAY
• MDR Report Key: 17955845
• MDR Text Key: 325907488
• Report Number: 3001587388-2023-23432
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/01/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PSO-PB
• Device Lot Number: 22C09209
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other