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

Model Number SLP82043

Device Problem Improper Chemical Reaction (2952)

Patient Problems Rash (2033); Skin Burning Sensation (4540)

Event Date 03/06/2021

Event Type  Injury  

Event Description

Skin burn/rash; when using the cpap cleaning system, (sleep 8), if i put my face mask and head gear in the cleaning bag, with my air tube and water bin for a single cleaning cycle, the face mask and head gear will burn my face.I have tried soaking and washing the mask and headgear in soapy water, and then use it, it will still burn.The only solution i have found, is to throw the headgear and mask away.I then use new mask and headgear and clean with cpap wipes.This has been tested by myself over a year and half of usage.Something is very wrong here.There is a chemical reaction that embeds in the silicone and straps of the headgear.I have contacted sleep 8, and i got the feeling that i will never hear from them again.The resulting burn/rash will last about a week.Fda safety report id # (b)(4).

• Brand Name: SLEEP 8
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SLEEP 8, INC
• MDR Report Key: 11482680
• MDR Text Key: 240335391
• Report Number: MW5099986
• 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: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SLP82043
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 136