inforMED
InjuryMRP

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

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.