InjuryNPF
GOODSMART 420 G-CPAC
Received Apr 15, 2007
Report MW5001850 · MDR key 847022
Device
Product problems
- Device Emits Odor
Patient
54 YR
- Dizziness
Narrative
Description of Event or Problem
PATIENT BOUGHT APNEA MACHINE FROM THE COMPANY. PATIENT COULD SMELL BURNING PLASTIC WHEN MACHINE WAS IN USE AND COMAPNY WOULD NOT TAKE THE MACHINE BACK. BREATHING THROUGH THIS DEVICE MADE THE PATIENT FEEL DIZZY. THIS DEVICE IS FAULTY AND FDA NEEDS TO DO SOMETHING ABOUT IT.