FDA Adverse Event
Death
Summary report: N
VIVE HEALTH LLC
MDR report key: 24376841
·
Received February 18, 2026
Report
- Report Number
- 3011191255-2026-10015
- Event Type
- Death
- Date Received
- February 18, 2026
- Date of Event
- September 8, 2024
- Report Date
- January 29, 2026
- Manufacturer
- VIVE HEALTH
- Product Code
- QTC
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
A COMPLAINT WAS RECEIVED ALLEGING THAT A CUSTOMER BECAME ENTANGLED IN A VIVE BED RAIL AND SUBSEQUENTLY DIED FROM ASPHYXIATION. NO FURTHER DETAILS ABOUT THE CIRCUMSTANCES OR CONTRIBUTING FACTORS ARE AVAILABLE AT THIS TIME. THE EVENT IS UNDER INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 435907 | VIVE HEALTH LLC | COMPACT BED RAIL | QTC | VIVE HEALTH | LVA2009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR | Male | Death |