MAUDE Adverse Event Report: INTERNATIONAL BIOMEDICAL LTD AIRBORNE TRANSPORT INCUBATORS A 750I; INCUBATOR, NEONATAL TRANSPORT

Model Number A 750I

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2016

Event Type  malfunction  

Event Description

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.

• Brand Name: AIRBORNE TRANSPORT INCUBATORS A 750I
• Type of Device: INCUBATOR, NEONATAL TRANSPORT
• Manufacturer (Section D): INTERNATIONAL BIOMEDICAL LTD; 8206 cross park dr.; austin TX 78754
• MDR Report Key: 5549836
• MDR Text Key: 41975163
• Report Number: 5549836
• Device Sequence Number: 1
• Product Code: FPL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A 750I
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2016
• Device Age: 6 YR
• Event Location: Other
• Date Report to Manufacturer: 03/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1