MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-07-24 for AIR SHIELDS TI 600 GLOBETROTTER HIGHHOOD TRANSPORT SYSTEM TI 500 UNK manufactured by Hillrom (airshields).
[166849]
Pt being transferred to hosp via ambulance. After exiting ambulance and prior to entering hosp, isolette hit a pot hole and tipped over. Baby rolled over on side and started crying. No lines or tubes were disturbed. Both paramedics were holding onto gurney. Isolette did not dislodge from gurney. Pt was not restrained inside isolette. This new isolette has disposable restraint straps and there was only 1 restraint strap in transporter instead of two so restraint was not in a useable condition. Isolette is top heavy. Two md's witnessed fall, ran outside to assist. No medical intervention required. Assessed need for head ultrasound not done because no medical need existed. No apparent injury to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019372 |
| MDR Report Key | 287279 |
| Date Received | 2000-07-24 |
| Date of Report | 2000-07-24 |
| Date of Event | 2000-07-06 |
| Date Added to Maude | 2000-07-28 |
| 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 | RISK MANAGER |
| 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 | AIR SHIELDS TI 600 GLOBETROTTER HIGHHOOD TRANSPORT SYSTEM |
| Generic Name | NEONATAL TRANSPORTER |
| Product Code | FPL |
| Date Received | 2000-07-24 |
| Model Number | TI 500 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | 6736990 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 277990 |
| Manufacturer | HILLROM (AIRSHIELDS) |
| Manufacturer Address | 330 JACKSON RD HATBORO PA 190402211 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 2000-07-24 |