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
Manufacturer
Draegerwerk Ag & Co. KgaaCatalog number
8411130
Patient
2 MO · Male
- Insufficient Information
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).