inforMED
MalfunctionNPF

SMART MONITOR 2

Received Dec 28, 2022 · Event occurred Dec 26, 2022

Report MW5114075 · MDR key 16069557

Device

Generic name

Apnea Monitor

Model number

4002

Product problems

  • Device Emits Odor
  • Overheating of Device
  • Smoking
  • Noise, Audible

Patient

5 MO · Male

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

MY SON IS ON RESPIRONICS SMART MONITOR 2 AT HOME, AND I TURNED THE MACHINE OFF TO GIVE HIM A BATH. I WENT TO TURN THE MACHINE BACK ON AFTERWARDS, ALL THE LIGHTS LIT UP, IT BEEPED, AND THEN I SMELLED BURNING PLASTIC. THE MACHINE HEATED UP AND STARTED TO SMOKE EVEN AFTER IT WAS UNPLUGGED AND OFF. IT EVENTUALLY COOLED DOWN AND STOPPED SMOKING AFTER A FEW MINUTES. THE DME(DURABLE MEDICAL EQUIPMENT) SWAPPED OUT THE DEVICE.