MAUDE Adverse Event Report: SOPHYSA PRESSIO 2 MONITOR; ICP & ICT MONITORING

Model Number PSO-4000

Device Problem No Device Output (1435)

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

Event Date 10/25/2020

Event Type  malfunction  

Manufacturer Narrative

Pending device analysis.

Event Description

The scrub team switched on the pso 4000 as usual and prepared a catheter pso ptt for zeroing.The screen was flashing connect catheter as usual.When the scout nurse connected the catheter the pso 4000 did not recognise that they had plugged it in and kept flashing connect catheter.This was tried several times and rep then advised them to turn off and restart monitor and plug the catheter back in for zeroing.This didn't resolve the situation so the rep advised another catheter to be opened.The same problem still persisted with a second catheter.The unit also started to go blank screen and restart on its own.The patient was kept in theatre for an additional 45 minutes while another monitor was taken to be used instead.

• Brand Name: PRESSIO 2 MONITOR
• Type of Device: ICP & ICT MONITORING
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besancon, 25000 ; FR 25000
• Manufacturer Contact: hanta ranaivoson ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 11072017
• MDR Text Key: 223620632
• Report Number: 3001587388-2020-20670
• Device Sequence Number: 1
• Product Code: GWM
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/24/2020

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
• Device Operator: No Information
• Device Model Number: PSO-4000
• Device Catalogue Number: PSO-4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention