MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-12-27 for INFANT TRANSPORT INCUBATOR TI100-1 manufactured by Air Shields Vickers.
[5574]
Transport incubator was being returned to labor and delivery after transport of newborn. Incubator was empty at the time. Smoke and flames were observed coming from battery tray after incubator was plugged in to recharge. Fire alarm was sounded and pressurized water extinguisher was used to put out fire. Unit was turned over to biomedical engineering for examination. No adverse pt outcome. Battery tray was returned to co for failure analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1004564 |
| MDR Report Key | 18536 |
| Date Received | 1994-12-27 |
| Date Added to Maude | 1994-12-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFANT TRANSPORT INCUBATOR |
| Generic Name | INFANT TRANSPORT INCUBATOR |
| Product Code | FPL |
| Date Received | 1994-12-27 |
| Returned To Mfg | 1994-12-14 |
| Model Number | TI100-1 |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 18464 |
| Manufacturer | AIR SHIELDS VICKERS |
| Manufacturer Address | HATBORO PA 19040 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-12-27 |