MAUDE Adverse Event Report: SLEEP 8, INC. SLEEP8 CPAP COMPANION SYSTEM; DISINFECTANT, MEDICAL DEVICES

Model Number SLP82043

Device Problems Patient-Device Incompatibility (2682); Environmental Compatibility Problem (2929)

Patient Problems Erythema (1840); Inflammation (1932); Itching Sensation (1943); Swelling/ Edema (4577)

Event Date 07/12/2021

Event Type  Injury  

Event Description

Reaction to ozone exposure; using sleep8 ozone cpap cleaner and began having facial skin reaction.I thought i had developed a silicone allergy.It would take 3-5 days for the skin reaction (distinct swelling, redness and itching) to resolve.As soon as i used my cpap again the skin reaction would return.I got a completely new cpap setup including machine and mask and for three weeks was able to use the cpap every night without any skin irritation.On (b)(6) 2021 i put the hose and mask into the sleep8 ozone cpap cleaner and ran the cleaning cycle.Just prior to going to sleep, i removed the hose and mask from the sleep8 cleaning bag, and began my cpap therapy for the night.I woke with swelling, redness and itching in distinct red splotches where my mask touched face (specifically under lower lip and cheeks).More research online brought me to a similar report: https://www.Accessdata.Fda.Gov/scripts/cdrh/cfdocs/cfmaude/detail.Cfm?mdrfoi__id=10689847&pc=lrj.Fda safety report id # (b)(4).

• Brand Name: SLEEP8 CPAP COMPANION SYSTEM
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SLEEP 8, INC.
• MDR Report Key: 12173124
• MDR Text Key: 261936611
• Report Number: MW5102543
• Device Sequence Number: 1
• Product Code: LRJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SLP82043
• Device Catalogue Number: SLEEP8 CPAP COMPANION SYSTEM
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 65