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 |