FDA Adverse Event
Malfunction
Summary report: N
WALKMED 350VL
MDR report key: 23356461
·
Received October 22, 2025
Report
- Report Number
- 23356461
- Event Type
- Malfunction
- Date Received
- October 22, 2025
- Date of Event
- February 3, 2025
- Report Date
- September 30, 2025
- Manufacturer
- WALKMED TECHNOLOGIES, LLC
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- RI
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 0
PUMP WAS PERSISTENTLY ALARMING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 285416 | WALKMED 350VL | PUMP, INFUSION | FRN | WALKMED TECHNOLOGIES, LLC | ABF13110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |