FDA Adverse Event
Malfunction
Summary report: N
VENTR. TUNNEL. PRESS. KIT
MDR report key: 968443
·
Received December 20, 2007
Report
- Report Number
- 2023988-2007-00078
- Event Type
- Malfunction
- Date Received
- December 20, 2007
- Report Date
- December 20, 2007
- Manufacturer
- INTEGRA NEUROSCIENCES
- Product Code
- HCA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER ZERO BALANCING, ICP MONITORING WAS CONDUCTED FOR A WHILE; HOWEVER, THE ERROR CODE EOB WAS DISPLAYED AND MONITORING BECAME IMPOSSIBLE. THE FAULTY CATHETER WAS REPLACED. THE CUSTOMER DISPOSED OF THE CATHETER. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTR. TUNNEL. PRESS. KIT | NONE | HCA | INTEGRA NEUROSCIENCES | W051090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |