FDA.reportPublic FDA data

MAUDE MDR 6785132

MDR report key
6785132
Report number
MW5071483
Event key
0
Event type
3
Date of event
2017-04-01
Date received
2017-08-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WINX SLEEP MACHINEWINXAPNICUREOZRONLY ONE MODELI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-0801. R

Event Narratives#

D

Patient 1

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.