FDA Adverse Event
Other
Summary report: N
SC7000
MDR report key: 511044
·
Received January 14, 2004
Report
- Report Number
- 1220063-2004-00001
- Event Type
- Other
- Date Received
- January 14, 2004
- Date of Event
- December 12, 2003
- Report Date
- January 13, 2004
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC.
- Product Code
- DSI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED: IN THE EMERGENCY ROOM, A NURSE WAS ATTEMPTING TO DOCK THE PT MONITOR ONTO THE DOCKING STATION AND IT WAS NOTED THAT THE MONITOR FELL OFF OF THE DOCKING STATION AND HIT THE FLOOR. THERE WAS NO INJURY INVOLVED. A BIOMED AT THE FACILITY PERFORMED AN EVALUATION OF THE DOCKING STATION AND REPORTED THAT THE CONNECTION DOOR COVER / LOCKING MECHANISM ON THE DOCKING STATION WAS LOOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SC7000 | MODULAR PT MONITOR | DSI | DRAEGER MEDICAL SYSTEMS, INC. | 5202994E539U | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other | DRAEGER MEDICAL SYSTEMS - INFINITY DOCKING STATION| (PN 5594887EE56U). |