PARENCHYMAL PRESSIO CATHETER
Report
- Report Number
- 3001587388-2017-17349
- Event Type
- Malfunction
- Date Received
- December 19, 2017
- Date of Event
- July 14, 2017
- Report Date
- July 28, 2017
- Manufacturer
- SOPHYSA SA
- Product Code
- GWM
- PMA / PMN Number
- K062584
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE PROBE HAS NOT YET BEEN RETURNED BY THE HOSPITAL. INTERNAL DOCUMENTATION SHOWS THAT ICP PROBE HAS BEEN MANUFACTURED IN ACCORDANCE WITH QUALITY REQUIREMENTS. THE ANALYSIS WILL MAKE IT POSSIBLE TO KNOW THE CAUSES OF THE APPEARANCE OF THIS INCIDENT.
THE INTERNAL DOCUMENTATION HAS BEEN REVIEWED AND SHOWS ANY PERFORMANCE ABNORMALITY OR ANY CAUSALITY RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE SUSPECTED DEVICE. A FIRST VISUAL ANALYSIS WAS PERFORMED AND SHOWED THAT THE RETURNED CATHETER WAS CLEAN AND WITHOUT VISUAL DEFECTS. A FUNCTIONAL ANALYSIS WAS THEN PERFORMED. ACCORDING TO THIS ANALYSIS, THE CATHETER REACTS NORMALLY TO THE IMPOSED PRESSURE VARIATIONS. OUR QUALITY CONTROL DEPARTMENT WAS UNABLE TO REPRODUCE THE DEFECT OBSERVED BY THE USER AND THUS THE DEFECT CAN NOT BE CONFIRMED. IN CONCLUSION, THE CATHETER DOES MEET ITS SPECIFICATION.
PRESSURE CURVE SHOWED ARTEFACTS ON ICP MONITOR. THEN ICP PROBE HAS BEEN CHANGED AND ARTEFACTS DISAPPEARED.
PRESSURE CURVE SHOWED ARTEFACTS ON ICP MONITOR. THEN ICP PROBE HAS BEEN CHANGED AND ARTEFACTS DISAPPEARED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 911853 | PARENCHYMAL PRESSIO CATHETER | ICP PRESSURE MONITORING CATHETER | GWM | SOPHYSA SA | ICP CATHETER | E0186 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |