MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-04-22 for INTERNATIONAL BIOMEDICAL 20H 731-0260 manufactured by International Biomedical.
[16270171]
Pt in transport isolette involved in head-on collision. Isolette bar snapped, (bar used to anchor isolette to ambulance). Isolette sustained various forms of damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1028205 |
| MDR Report Key | 455372 |
| Date Received | 2003-04-22 |
| Date of Report | 2003-04-22 |
| Date of Event | 2003-02-23 |
| Date Added to Maude | 2003-04-24 |
| 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 | INTERNATIONAL BIOMEDICAL |
| Generic Name | TRANSPORT INCUBATOR (UNIVERSAL CART) |
| Product Code | FPL |
| Date Received | 2003-04-22 |
| Model Number | 20H |
| Catalog Number | 731-0260 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 444355 |
| Manufacturer | INTERNATIONAL BIOMEDICAL |
| Manufacturer Address | 8508 CROSS PARK DRIVE AUSTIN TX 787544532 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2003-04-22 |