inforMED
InjuryCBK

NEONATAL FLOW SENSOR ISO 15

Received Jan 2, 2026 · Event occurred Dec 23, 2025

Report MW5181606 · MDR key 23945656

Device

Generic name

Ventilator, Continuous, Facility Use

Catalog number

8411130

Patient

2 MO · Male

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Narrative

Description of Event or Problem

INFANT ON DRAGER EVITA INFINITY 500 VENTILATOR. VENTILATOR ALARMED FOR HIGH RESPIRATORY RATE AND FLOW SENSOR MEASUREMENT INACCURATE. UPON INSPECTION OF CIRCUIT, SPARKS WERE INTERMITTENTLY PRESENT WITHIN THE NEONATAL FLOW SENSOR (P/N: 8411130). NO SIGNIFICANT AMOUNT OF CONDENSATION WAS FOUND IN THE CIRCUIT AT THE TIME. INFANT REMAINED CLINICALLY STABLE WHILE FLOW SENSOR WAS REPLACED AND CALIBRATED. USED WITH FISHER & PAYKEL MR850 HUMIDIFIER AND AIRLIFE STERILE WATER (REF: 2D0735X).