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 |