FDA Adverse Event
Malfunction
Summary report: N
NUVISION ICE CATHETER
MDR report key: 20586646
·
Received November 1, 2024
Report
- Report Number
- 20586646
- Event Type
- Malfunction
- Date Received
- November 1, 2024
- Date of Event
- October 14, 2024
- Report Date
- October 16, 2024
- Manufacturer
- NUVERA MEDICAL, INC.
- Product Code
- OBJ
- UDI-DI
- 00860005688104
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
ERROR CODE " THE PROBE MAY HAVE A TECHNICAL ISSUE." PLEASE RECONNECT AND RESELECT PROBE - NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2161381 | NUVISION ICE CATHETER | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | NUVERA MEDICAL, INC. | FG10593 | 31310311LN | 00860005688104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male |