MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-10-03 for TI 100 ROADRUNNER INFANT INCUBATOR manufactured by Hill-rom/ Air Shields.
[209007]
Roadrunner incubator stopped working and developed a burning smell. Unit had bad battery and power supply. Replaced both and reported to mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022998 |
| MDR Report Key | 354589 |
| Date Received | 2001-10-03 |
| Date of Report | 2001-09-28 |
| Date of Event | 2001-08-13 |
| Date Added to Maude | 2001-10-09 |
| 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 | TI 100 ROADRUNNER INFANT INCUBATOR |
| Generic Name | TRANSPORT INCUBATOR |
| Product Code | FPL |
| Date Received | 2001-10-03 |
| Model Number | TI 100 ROADRUNNER |
| Catalog Number | TI 100 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 343809 |
| Manufacturer | HILL-ROM/ AIR SHIELDS |
| Manufacturer Address | 330 JACKSONVILLE RD HATBORO PA 190402211 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-10-03 |