AIRBORNE TRANSPORT INCUBATORS A 750I

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number5549836
MDR Report Key5549836
Date Received2016-04-06
Date of Report2016-03-30
Date of Event2016-03-25
Report Date2016-03-30
Date Reported to FDA2016-03-30
Date Reported to Mfgr2016-03-30
Date Added to Maude2016-04-06
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAIRBORNE TRANSPORT INCUBATORS A 750I
Generic NameINCUBATOR, NEONATAL TRANSPORT
Product CodeFPL
Date Received2016-04-06
Model NumberA 750I
Device AvailabilityY
Device Age6 YR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTERNATIONAL BIOMEDICAL LTD
Manufacturer Address8206 CROSS PARK DR. AUSTIN TX 78754 US 78754


Patients

Patient NumberTreatmentOutcomeDate
10 2016-04-06

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