MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-07-14 for GLOBETROTTER NEONATAL TRANSPORT SYSTEM GT500 manufactured by Drager Medical Systems, Inc. (pnc).
[1596091]
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).
Patient Sequence No: 1, Text Type: D, B5
[8607561]
We are still investigating this report. A follow up report will be submitted as soon as we complete our investigation.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 2510954-2010-00007 |
MDR Report Key | 1760789 |
Report Source | 05 |
Date Received | 2010-07-14 |
Date of Report | 2010-06-16 |
Date of Event | 2010-05-24 |
Device Manufacturer Date | 2007-07-01 |
Date Added to Maude | 2011-04-08 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | BIOMEDICAL ENGINEER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Contact | REBECCA DOLLOFF |
Manufacturer Street | 3135 QUARRY ROAD |
Manufacturer City | TELFORD PA 18969 |
Manufacturer Country | US |
Manufacturer Postal | 18969 |
Manufacturer Phone | 9783798573 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | GLOBETROTTER NEONATAL TRANSPORT SYSTEM |
Generic Name | NEONATAL TRANSPORT INCUBATOR |
Product Code | FPL |
Date Received | 2010-07-14 |
Model Number | GT500 |
Catalog Number | NA |
Lot Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | DRAGER MEDICAL SYSTEMS, INC. (PNC) |
Manufacturer Address | 3135 QUARRY ROAD TELFORD PA 18969 US 18969 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2010-07-14 |