FDA Adverse Event
Malfunction
Summary report: N
RAPID INFUSER RI-2
MDR report key: 16768506
·
Received April 19, 2023
Report
- Report Number
- 16768506
- Event Type
- Malfunction
- Date Received
- April 19, 2023
- Date of Event
- January 9, 2023
- Report Date
- April 12, 2023
- Manufacturer
- BELMONT INSTRUMENT LLC
- Product Code
- LGZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
TRIPPED CIRCUIT BREAKER AND SHUTDOWN POWER TO THE OPERATING ROOM. FACILITIES DEPARTMENT NOTIFIED TO HELP RESET CIRCUIT BREAKERS DURING A CRITICAL PORTION OF SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1443758 | RAPID INFUSER RI-2 | WARMER, THERMAL, INFUSION FLUID | LGZ | BELMONT INSTRUMENT LLC | 903-00037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20440 DA | Male |