FDA Adverse Event
Malfunction
Summary report: N
VENTRICULAR TUNNELING PRESSURE MONITORING
MDR report key: 527511
·
Received February 25, 2004
Report
- Report Number
- 2023988-2004-00018
- Event Type
- Malfunction
- Date Received
- February 25, 2004
- Report Date
- February 25, 2004
- Manufacturer
- INTEGRA NEUROCARE LLC
- Product Code
- HCA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PHYSICIAN REPORTED NO PROBLEMS WERE NOTED DURING THE INSERTION PROCEDURE. THE CATHETER WAS PROPERLY OPENED, ZEROED ADN CONNECTED TO THE MONITOR. ZERO APPEARED ON THE DISPLAY, THEN THE PHYSICIAN STARTED TO INSERT THE CATHETER. DURING INSERTION OF THE CATHETER THE PHYSICIAN NOTICIED AN ERROR MESSAGE "E01" ON THE DISPLAY. THE MONITOR WAS TURNED OFF AND ON DISPLAYING "----".A FEW SECONDS LATER THE "E01" ERROR MESSAGE REAPPEARED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTRICULAR TUNNELING PRESSURE MONITORING | NEURO MONITORING | HCA | INTEGRA NEUROCARE LLC | * | V1278 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |