MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-03-04 for TI100 GLOBE TROTTER NA manufactured by Hill-rom Airshields.
[357391]
A unit caught fire in the back of an ambulance - seriously damaging the vehicle. No pt was involved. There were no injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2510954-2004-00002 |
| MDR Report Key | 533348 |
| Report Source | 00 |
| Date Received | 2004-03-04 |
| Date of Report | 2004-03-02 |
| Date of Event | 2004-01-23 |
| Date Mfgr Received | 2004-01-26 |
| Device Manufacturer Date | 1995-05-01 |
| Date Added to Maude | 2004-07-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MONICA FERRANTE |
| Manufacturer Street | 330 JACKSONVILLE ROAD |
| Manufacturer City | HATBORO PA 19040 |
| Manufacturer Country | US |
| Manufacturer Postal | 19040 |
| Manufacturer Phone | 2156828691 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TI100 GLOBE TROTTER |
| Generic Name | TRANSPORT INCUBATOR |
| Product Code | FPL |
| Date Received | 2004-03-04 |
| Model Number | TI100 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 522617 |
| Manufacturer | HILL-ROM AIRSHIELDS |
| Manufacturer Address | 330 JACKSONVILLE RD. HATBORO PA 19040 US |
| Baseline Brand Name | TI100 TRANSPORT INCUBATOR |
| Baseline Generic Name | TRANSPORT INCUBATOR |
| Baseline Model No | TI100 |
| Baseline Catalog No | 6730070 |
| Baseline ID | GP00561 |
| Baseline Device Family | TRANSPORT INCUBATOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K831028 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-03-04 |