FDA Adverse Event
Injury
Summary report: N
8400 STI
MDR report key: 314673
·
Received January 12, 2001
Report
- Report Number
- 2021710-2001-00002
- Event Type
- Injury
- Date Received
- January 12, 2001
- Date of Event
- December 14, 2000
- Report Date
- January 11, 2001
- Manufacturer
- BIRD PRODUCTS CORPORATION
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
UNIT FAILED ON PATIENT. NO PT INJURY REPORTED. UNIT WENT OFF AND NEVER CAME BACK ON, ERROR CODE 182-182.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1557 | 8400 STI | CONTINUOUS VENTILATOR | CBK | BIRD PRODUCTS CORPORATION | 8400 STI | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |