MalfunctionMRN
AERONOX NITRIC OXIDE DELIVERY DEVICE
Received Feb 7, 2019 · Event occurred Jan 25, 2019
Report 8314379 · MDR key 8314379
Device
Generic name
Apparatus, Nitric Oxide Delivery
Manufacturer
International Biomedical, Ltd.Model number
AERONOXCatalog number
731-9148
Product problems
- Loss of Power
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
WHILE WALKING DOWN THE HALL AT NEWBORN INTENSIVE CARE UNIT (NICU) TO TRANSPORT A PATIENT, THE AERONOX 2.0 TURNED OFF. THE UNIT WAS PLUGGED IN AND CHARGED PRIOR TO USE. NO HARM TO PATIENT REPORTED. MANUFACTURER RESPONSE FOR APPARATUS, NITRIC OXIDE DELIVERY, AERONOX NITRIC OXIDE DELIVERY DEVICE (PER SITE REPORTER). MANUFACTURER WAS INFORMED TODAY ABOUT THE PROBLEM. THERE IS NO OFFICIAL RESPONSE YET.