FDA Adverse Event
Malfunction
Summary report: N
GOODKNIGHT 4200
MDR report key: 607630
·
Received May 20, 2005
Report
- Report Number
- 9615679-2005-00001
- Event Type
- Malfunction
- Date Received
- May 20, 2005
- Date of Event
- January 7, 2005
- Report Date
- January 28, 2005
- Manufacturer
- MALLINCKRODT DEVELOPPEMENT FRANCE
- Product Code
- BYE
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
THE PT SAID AC/DC POWER SUPPLY BURNT AND FLAMES HAD BEEN PROJECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GOODKNIGHT 4200 | NASAL CPAP SYSTEM | BYE | MALLINCKRODT DEVELOPPEMENT FRANCE | M-113900-US | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |