FDA Adverse Event
Malfunction
Summary report: N
EIGHT SLEEP POD 5
MDR report key: 23979776
·
Received January 6, 2026
Report
- Report Number
- MW5181856
- Event Type
- Malfunction
- Date Received
- January 6, 2026
- Report Date
- December 30, 2025
- Manufacturer
- EIGHT SLEEP, INC
- Product Code
- SBO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
PRODUCT FREQUENTLY FAILS AND DOES NOT ADDRESS CLAIMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47839 | EIGHT SLEEP POD 5 | BED-PATIENT ACTIVITY MONITORING SYSTEM | SBO | EIGHT SLEEP, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |