TI500 Globetrotter Neonatal Transport System MU20508Recalls & reported problems
Draeger Medical Systems, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049098000192), received between Oct 28, 2024 and Oct 28, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Key or Button Unresponsive/not Working” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K001019); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Key or Button Unresponsive/not Working1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2024 THE TRANSPORT INCUBATOR 500 (TI500) GLOBE TROTTER HAD AN ISSUE WITH THE TEMPERATURE ADJUST BUTTON AND THE VENTILATOR HAD AN ISSUE MAINTAINING PRESSURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE WAS INSPECTED AND SERVICED BY DRAEGER ENGINEERING AND FOUND THAT THE REPORTED PROBLEMS ONLY OCCURRED INTERMITTENTLY. THE ISSUE RELATED TO THE UNRESPONSIVE TEMPERATURE ADJUST BUTTON WAS CONFIRMED DURING DRAEGER'S INSPECTION OF THE DEVICE. DRAGER SERVICE FOLLOWED SERVICE SOFTWARE FOR REPAIR INSTRUCTIONS AND REPLACED THE TEMPERATURE CONTROLLER TO RESOLVE THE ISSUE. THE CUSTOMER'S CONCERN WITH THE VENTILATOR NOT HOLDING PRESSURE WAS NOT ABLE TO BE REPRODUCED DURING SERVICE. THE DEVICE WAS TESTED AND CONFIRMED TO HAVE BEEN OPERATING PER THE MANUFACTURER'S SPECIFICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20545945 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K001019. One submission often covers many models, so check the product and lot details in each record.
- Z-1053-2008 · Jan 31, 2008 · TerminatedDraeger Globe Trotter IC, Catalog Number: MU20509, Draeger Medical, Inc., Telford, PA 18969
- Z-1052-2008 · Jan 31, 2008 · TerminatedDraeger GT500. GlobeTrotter Transport System. Catalog Number: MU20508, Draeger Medical, Inc., Telford, PA 18969
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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