NOXBOX INHALED NITRIC OXIDE DELIVERY SYSTEM
Received Jul 11, 2024 · Event occurred Jul 7, 2024
Report MW5157242 · MDR key 19730693
Device
Generic name
Analyzer, Nitric Oxide
Manufacturer
Praxair/linde Gas & Equipment Inc.Patient
5 MO · Prefer Not To Disclose
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
PRAXAIR/LINDE NOXBOX INHALED NITRIC OXIDE SYSTEM EXPERIENCING SWINGS IN DELIVERED INHALED NITRIC OXIDE WHEN USED WITH HIGH FREQUENCY JET VENTILATOR (HFJV). THE HFJV HAD TO HAVE SETTINGS MANIPULATED IN ORDER TO BALANCE AND STABILIZE THE DESIRED PARTS PER MILLION (PPM) OF INHALED NITRIC OXIDE. HAVE HAD SIMILAR EXPERIENCES WHEN THE NOXBOX IS USED WITH HIGH FREQUENCY OSCILLATOR VENTILATOR (HFOV). PRAXAIR HAS BEEN MADE AWARE OF THE ISSUE AND IS UNABLE TO PROVIDE DIRECTION TO CORRECT THE SITUATION OTHER THAN TO INDICATE MANIPULATING VENTILATOR SETTINGS. THIS IS OCCURRING IN THE NEONATAL INTENSIVE CARE UNIT (NICU), WHERE PRECISE VENTILATOR SETTINGS ARE REQUIRED AND EVEN THE SLIGHTEST VARIATION IN SETTINGS CAN HAVE SIGNIFICANT IMPACT ON THE PATIENT CARE. PRAXAIR/LINDE, DANBURY, CT 06810 US.