GLOBETROTTER NEONATAL TRANSPORT SYSTEM GT500

MAUDE Adverse Event Report

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).

Event Text Entries

[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


MAUDE Entry Details

Report Number2510954-2010-00007
MDR Report Key1760789
Report Source05
Date Received2010-07-14
Date of Report2010-06-16
Date of Event2010-05-24
Device Manufacturer Date2007-07-01
Date Added to Maude2011-04-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactREBECCA DOLLOFF
Manufacturer Street3135 QUARRY ROAD
Manufacturer CityTELFORD PA 18969
Manufacturer CountryUS
Manufacturer Postal18969
Manufacturer Phone9783798573
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGLOBETROTTER NEONATAL TRANSPORT SYSTEM
Generic NameNEONATAL TRANSPORT INCUBATOR
Product CodeFPL
Date Received2010-07-14
Model NumberGT500
Catalog NumberNA
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDRAGER MEDICAL SYSTEMS, INC. (PNC)
Manufacturer Address3135 QUARRY ROAD TELFORD PA 18969 US 18969


Patients

Patient NumberTreatmentOutcomeDate
10 2010-07-14

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