MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-08 for WINX SLEEP MACHINE ONLY ONE MODEL manufactured by Apnicure.
[82492125]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071483 |
| MDR Report Key | 6785132 |
| Date Received | 2017-08-08 |
| Date of Report | 2017-08-08 |
| Date of Event | 2017-04-01 |
| Date Added to Maude | 2017-08-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WINX SLEEP MACHINE |
| Generic Name | WINX |
| Product Code | OZR |
| Date Received | 2017-08-08 |
| Model Number | ONLY ONE MODEL |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APNICURE |
| Manufacturer Address | CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-08 |