inforMED
MalfunctionBXY

LOW RANGE FLOWMETER

Received Nov 9, 2015 · Event occurred Aug 5, 2014

Report 5210377 · MDR key 5210377

Device

Generic name

Flowmeter, Calibration, Gas

Model number

KIT NO. 537-1

Catalog number

NA

Lot number

NA

Product problems

  • Device Operates Differently Than Expected

Patient

0 YR

  • Hypoxia

Narrative

Description of Event or Problem

PATIENT IS GETTING OXYGEN EQUIPMENT FROM A HOME CARE MEDICAL AND RESPIRATORY EQUIPMENT PROVIDER. THE PARENTS ARE REPORTING THAT THE HUMIDIFICATION BUBBLE MALFUNCTIONED WHICH CAUSED WATER TO GET INTO THE NASAL CANNULA TUBING AND THEN FROM THERE INTO THE NASAL/ORAL PHARYNX. THIS CAUSED THE PATIENT TO HAVE TO GO TO THE HOSPITAL WHERE SHE PRESENTED WITH HYPOXIA. THE ATTENDING DOCTOR WOULD LIKE TO HAVE THAT EQUIPMENT PICKED UP AND BROUGHT INTO THE HOSPITAL FOR INSPECTION.