AIRBORNE 750I
Received Jun 7, 2021 · Event occurred May 27, 2021
Report 11945903 · MDR key 11945903
Device
Generic name
Incubator, Neonatal Transport
Manufacturer
International BiomedicalModel number
A750ICatalog number
731-0160
Product problems
- Thermal Decomposition of Device
- Device Emits Odor
- Material Deformation
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
DURING SET UP AND PREPARATION OF THE IN-HOUSE TRANSPORT ISOLETTE, THE NURSE NOTICED A STRONG ELECTRICAL SMELL FROM THE ISOLETTE CHAMBER. SHE IMMEDIATELY UNPLUGGED THE UNIT FROM AC POWER AND REMOVED THE ISOLETTE FROM THE CARE AREA. BIOMEDICAL ENGINEERING RETRIEVED THE UNIT AND OPENED DEVICE FOR INSPECTION. THE BME FOUND THE HIGH CURRENT BRIDGE RECTIFIER BURNT ALONG WITH THE BRIDGE LEAD GOING TO THE POWER TERMINAL BLOCK. THE BME ALSO NOTED SWELLING OF THE 12V 28AH INTERNAL BATTERY. REVIEW OF THE SERVICE HISTORY ON THIS ISOLETTE AND OTHER OF THE SAME MODEL NOTED THE SAME COMPONENT FAILURE IN TWO PREVIOUS REPAIRS ON TWO SEPARATE DEVICES. PARTS ORDERED AND ISOLETTE SCHEDULED FOR REPAIR.