inforMED
InjuryNPF

GOODSMART 420 G-CPAC

Received Apr 15, 2007

Report MW5001850 · MDR key 847022

Device

Generic name

Apnea Machine

Manufacturer

Puritan Bunnett

Model number

UNK

Catalog number

UNK

Lot number

UNK

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.