MalfunctionMRN

AERONOX NITRIC OXIDE DELIVERY DEVICE

Received Jul 1, 2019 · Event occurred Jun 6, 2019

Report 8748159 · MDR key 8748159

Device

Generic name

Apparatus, Nitric Oxide Delivery

Manufacturer

International Biomedical, Ltd.

Model number

AERONOX

Catalog number

731-9148

Product problems

Loss of Power

Patient

Not reported

No Patient Involvement
No Patient Involvement

Narrative

Description of Event or Problem

WHILE PREPARING TO TRANSPORT A PATIENT ON A HELICOPTER, WHILE TESTING THE UNIT BEFORE USE, IT TURNED OFF AFTER A COUPLE MINUTES OF BEING TURNED ON. THE DEVICE HAD A NEW BATTERY REPLACED ON (B)(6) 2019 AND IT WAS SERVICED BY THE MANUFACTURER ON (B)(6) 2018. THE UNIT WAS MAINTAINED ON A CHARGE CYCLE. UPON REVIEWING RECORDS, THERE HAS BEEN A COUPLE OF INSTANCES ON VARIOUS UNITS WITH THE SAME BATTERY ISSUE.