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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SLEEP 8, INC SLEEP8; DISINFECTANT, MEDICAL DEVICES
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SLEEP 8, INC SLEEP8; DISINFECTANT, MEDICAL DEVICES Back to Search Results
Model Number SLP82043
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problems Sore Throat (2396); Cough (4457)
Event Date 11/10/2020
Event Type  Injury  
Event Description
I used a ozone cleaner called sleep 8 for my cpap machine and developed a sore throat and cough afterwards, in hindsight i realized this has not been the first time this has happened.I followed the manufacturer's direction and did not open the bag used to clean my equipment for 1 hour, their documentation claims the mask and tubes are ready for use after this 1 hour time period.I also let my cpap run with the tube and mask hooked up to insure that no ozone was left in the mask (not a direction listed by manufacturer).The manufacturer also has a list of 11 dangers and warning on their guide, not one mentions that the cleaning could cause any respiratory issues or a sore throat.All testing of this equipment is on the electrical components and has no mention of the ozone concerns.Researching this issue, i came across a press release from the fda from feb 2020 and want to add my complaint to this issue.Fda safety report id # (b)(4).
 
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Brand Name
SLEEP8
Type of Device
DISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SLEEP 8, INC
MDR Report Key10843582
MDR Text Key216883672
Report NumberMW5097885
Device Sequence Number1
Product Code LRJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberSLP82043
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age62 YR
Patient Weight98
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