MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-06 for AIRBORNE TRANSPORT INCUBATORS A 750I manufactured by International Biomedical Ltd.
[41975162]
Patient Sequence No: 1, Text Type: N, H10
[41975163]
The orange wire running from the bridge rectifier to the transformer burnt up. All the wires and internal components are original from the factory. This caused a power failure and the isolette was unable to function.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5549836 |
| MDR Report Key | 5549836 |
| Date Received | 2016-04-06 |
| Date of Report | 2016-03-30 |
| Date of Event | 2016-03-25 |
| Report Date | 2016-03-30 |
| Date Reported to FDA | 2016-03-30 |
| Date Reported to Mfgr | 2016-03-30 |
| Date Added to Maude | 2016-04-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRBORNE TRANSPORT INCUBATORS A 750I |
| Generic Name | INCUBATOR, NEONATAL TRANSPORT |
| Product Code | FPL |
| Date Received | 2016-04-06 |
| Model Number | A 750I |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL BIOMEDICAL LTD |
| Manufacturer Address | 8206 CROSS PARK DR. AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-06 |