MAUDE Adverse Event Report: SLEEP 8, INC. SLEEP 8 MODEL SLP82043; DISINFECTANT, MEDICAL DEVICES

Model Number MODEL SLP82043

Device Problem Device Emits Odor (1425)

Patient Problems Headache (1880); Nausea (1970)

Event Date 07/01/2020

Event Type  Injury  

Event Description

I purchased a "sleep 8" ozone cleaner from the cpap shop on (b)(6) 2020.When it arrived about a week later, i used it according to the directions to "sanitize" my cpap dreamwear mask, tubing, and humidifier water tank.All of the items had a distinct noxious odor after the sanitizing process, however, written information led me to believe the odor was normal and would disappear over time.The silicone nose piece and tubing had a softer, sticky feel after sanitizing as well, and the silicone seal for the humidifier leaked air.Handling the silicone mask pieces also left a small amount of substance on my hands, which stunk and was difficult to wash away.I used the sanitized items with my cpap machine that night, and i was able to fall asleep despite the odor.The next morning i had a headache and was somewhat nauseous.These feelings abated throughout the day.I did not sanitize the mask on the second night, hoping the odor would go down.It did somewhat.The next morning i had another headache, but less nausea.I decided to try the sanitizing process once more.(i sanitized the equipment in the morning to give it plenty of time to air out.) the odor was just as strong and again seemed to result in a headache and nausea the next morning.I looked up ozone cleaners using the (b)(6) search engine and came to the fda website, where i learned the ozone cleaners did not have formal fda approval for cleaning cpap equipment.I discontinued using the sanitizer and discarded the affected mask and tubing.The headaches and nausea disappeared entirely.Fda safety report id# (b)(4).

• Brand Name: SLEEP 8 MODEL SLP82043
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SLEEP 8, INC.
• MDR Report Key: 10275757
• MDR Text Key: 199227340
• Report Number: MW5095523
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MODEL SLP82043
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 70 YR