FDA Adverse Event
Malfunction
Summary report: N
DELTA
MDR report key: 897406
·
Received August 14, 2007
Report
- Report Number
- 1220063-2007-00025
- Event Type
- Malfunction
- Date Received
- August 14, 2007
- Report Date
- August 14, 2007
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC.
- Product Code
- DRG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DRAEGER MEDICAL SYSTEMS INC. HAS RECEIVED INFORMATION FROM A CUSTOMER WHO REPORTED THAT, WHEN TRANSPORTING A PATIENT USING OUR DELTA MONITOR, IT DID NOT SWITCH FROM THE EXTERNAL TO INTERNAL BATTERY. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTA | DELTA PATIENT MONITOR | DRG | DRAEGER MEDICAL SYSTEMS, INC. | NOT INDICATED | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR |