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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SLEEP 8, INC. SLEEP8 CPAP CLEANER & SANITIZER DEVICE; DISINFECTANT, MEDICAL DEVICES
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SLEEP 8, INC. SLEEP8 CPAP CLEANER & SANITIZER DEVICE; DISINFECTANT, MEDICAL DEVICES Back to Search Results
Catalog Number SLP82043
Device Problem Device Emits Odor (1425)
Patient Problems Headache (1880); Nausea (1970)
Event Date 03/13/2021
Event Type  Injury  
Event Description
Received sleep8 cpap sanitizer from the cpap shop on (b)(6) 2021.Following instructions, cleaned my head gear, nasal pillow, and hose.No problems with sanitizer but left bad odor.Went to use cpap that night and immediately felt nauseated and got a severe headache after one minute.Stopped using and noticed smelly colorless residue on my face and hands.Could not wash off.Repeatedly washed all cpap equipment the following day using baby shampoo and soaked for hours in vinegar and water solution and could not remove odor.Was not able to use my cpap again the following night.Had to contact the cpap shop 5 times to get a return label.At the cpap shop, the unit is advertised as safe and says it has been used by the food and healthcare industry for decades.Fda safety report id# (b)(4).
 
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Brand Name
SLEEP8 CPAP CLEANER & SANITIZER DEVICE
Type of Device
DISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SLEEP 8, INC.
MDR Report Key11529632
MDR Text Key241503398
Report NumberMW5100128
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 03/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberSLP82043
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age43 YR
Patient Weight78
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