FDA Adverse Event
Malfunction
Summary report: N
FLUID MANAGEMENT SYSTEM
MDR report key: 492108
·
Received October 22, 2003
Report
- Report Number
- 1219702-2003-00004
- Event Type
- Malfunction
- Date Received
- October 22, 2003
- Date of Event
- September 23, 2003
- Manufacturer
- BELMONT INSTRUMENT CORP.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
THE ANESTHESIOLOGIST WAS USING THE SYSTEM FOR APPROXIMATELY 2 HOURS THEN THE SYSTEM SHUT OFF. THE BIOMEDICAL ENGINEER TRIED TO RESTART THE SYSTEM BUT IT WOULD NOT TURN ON. THE SYSTEM WAS CHANGED WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLUID MANAGEMENT SYSTEM | INFUSION PUMP WITH WARMER | FRN | BELMONT INSTRUMENT CORP. | FMS2000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |