FDA Adverse Event
Malfunction
Summary report: N
OOK SNOW
MDR report key: 23657059
·
Received November 26, 2025
Report
- Report Number
- 3009591865-2025-00030
- Event Type
- Malfunction
- Date Received
- November 26, 2025
- Date of Event
- October 28, 2025
- Report Date
- February 4, 2026
- Manufacturer
- UMANO MEDICAL INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
ITF WAS REPORTED THAT THE INTEGRATED BED EXIT SYSTEM OF A MEDICAL BED WAS ALLEGEDLY NOT GIVING AN AUDIBLE SIGNAL WHEN TRIGGERED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE INTEGRATED BED EXIT SYSTEM OF A MEDICAL BED WAS ALLEGEDLY NOT GIVING AN AUDIBLE SIGNAL WHEN TRIGGERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2812074 | OOK SNOW | HOSPITAL BED | FNL | UMANO MEDICAL INC. | FL36 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |