inforMED
InjuryOZR

WINX SLEEP MACHINE

Received Aug 8, 2017 · Event occurred Apr 1, 2017

Report MW5071483 · MDR key 6785132

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Product code (OZR)
Model (ONLY ONE MODEL)

Device

Generic name

Winx

Manufacturer

Apnicure

Model number

ONLY ONE MODEL

Product problems

  • Device Reprocessing Problem
  • Device Contamination With Biological Material

Patient

69 YR

  • Unspecified Infection
  • Unspecified Infection

Narrative

Description of Event or Problem

I USE THE WINX SLEEP MACHINE FOR MY SLEEP APNEA. THE WINX SYSTEM UTILIZES SURGICAL TUBING IN ITS SYSTEM. WHILE THE MANUFACTURER STATES THAT THE TUBING SHOULD BE RINSED WITH A MINIMAL AMOUNT OF WARM WATER AND THE CONTROL UNIT ON A WEEKLY BASIS FOR CLEANING PURPOSES, I AM CONCERNED THAT THERE IS BIOFILM CONTAMINATION POSSIBLE IN BOTH THE UNIT AND TUBING. I HAVE HAD SEVERAL BRONCHIAL INFECTIONS IN THE PAST 6 MONTHS THAT COULD POSSIBLY HAVE SOME RELATIONSHIP TO CLEANING PROTOCOLS. WHEN I REQUESTED INFORMATION REGARDING THE EFFICACY OF THE CURRENT CLEANING PROTOCOL FROM THE MANUFACTURER OF THE WINX SLEEP MACHINE I HAVE BEEN BASICALLY IGNORED. I HAVE ASKED THEM IF IT WAS POSSIBLE TO USE A ON THE SHELF DISINFECTING SOLUTION. I WAS TOLD FINALLY THAT IT WAS OKAY BUT IF THERE WERE ANY PROBLEMS WITH THE MACHINE MY WARRANTY WAS VOID. I ASKED IF THERE WERE APPROVED OR RECOMMENDED DISINFECTANTS AND WAS TOLD THERE WERE NONE. ASKED FOR MANY TIMES BUT NEVER PROVIDED.