FDA Adverse Event
Other
Summary report: N
GLOBETROTTER NEONATAL TRANSPORT SYSTEM
MDR report key: 1760789
·
Received July 14, 2010
Report
- Report Number
- 2510954-2010-00007
- Event Type
- Other
- Date Received
- July 14, 2010
- Date of Event
- May 24, 2010
- Report Date
- June 16, 2010
- Manufacturer
- DRAGER MEDICAL SYSTEMS, INC. (PNC)
- Product Code
- FPL
- PMA / PMN Number
- K001019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
WE ARE STILL INVESTIGATING THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED AS SOON AS WE COMPLETE OUR INVESTIGATION.
Description of Event or Problem · 1
AFTER ARRIVAL FROM A TRANSPORT FROM ANOTHER FACILITY, THE UNIT WAS SET TO "BATTERY" MODE. SUBSEQUENTLY AFTER A PERIOD OF TIME THE PNEUMATIC MODULE EMITTED SMOKE AND THEN CAUGHT FIRE. NO PATIENT STAFF INJURY WAS REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GLOBETROTTER NEONATAL TRANSPORT SYSTEM | NEONATAL TRANSPORT INCUBATOR | FPL | DRAGER MEDICAL SYSTEMS, INC. (PNC) | GT500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |