FDA Adverse Event
Malfunction
Summary report: N
VHOME
MDR report key: 25139585
·
Received May 11, 2026
Report
- Report Number
- MW5187936
- Event Type
- Malfunction
- Date Received
- May 11, 2026
- Date of Event
- April 30, 2026
- Report Date
- May 6, 2026
- Manufacturer
- REACT HEALTH/ 3B MEDICAL INC
- Product Code
- NOU
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
VENT WAS ACCIDENTLY DROPPED ABOUT A FOOT, THEN THE VENT SHUT DOWN TWICE. CAREGIVER REPLACED VENT, NO HARM TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97548 | VHOME | CONTINUOUS, VENTILATOR, HOME USE | NOU | REACT HEALTH/ 3B MEDICAL INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |