MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-19 for AVIATOR manufactured by International Biomedical.
[20926443]
Infant was placed in transport isolette in preparation for helicopter transport. After being placed in transport isolette, pt's condition started to decline. He was placed back in original isolette and started to improve. Unit was checked by manufacture's rep and it was found that air and o2 lines were switched going to mixer. Instructions for checking unit indicated that it should be checked at 60%, but this would not detect switched lines.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015223 |
| MDR Report Key | 1638181 |
| Date Received | 2010-03-19 |
| Date of Report | 2010-03-18 |
| Date of Event | 2010-03-07 |
| Date Added to Maude | 2010-03-24 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVIATOR |
| Generic Name | TRANSPORT INCUBATOR |
| Product Code | FPL |
| Date Received | 2010-03-19 |
| Model Number | AVIATOR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL BIOMEDICAL |
| Manufacturer Address | 8508 CROSS PARK DR. AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-03-19 |