FDA Adverse Event
Other
Summary report: N
DRAGER E-4 VENTILATOR
MDR report key: 509722
·
Received February 4, 2004
Report
- Report Number
- 509722
- Event Type
- Other
- Date Received
- February 4, 2004
- Date of Event
- August 1, 2003
- Report Date
- November 1, 2003
- Manufacturer
- DRAEGER MEDICAL, INC.
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VT, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE VENTILATOR SETTINGS WERE CHANGED WITHOUT MANIPULATION BY STAFF. IT WAS CONNECTED TO A PT BUT THE VENTILATOR WAS CHANGED WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRAGER E-4 VENTILATOR | VENTILATOR | CBK | DRAEGER MEDICAL, INC. | DRAGER E-4 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Other |