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

Model Number SLP82043

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Irritation (1941)

Event Date 05/18/2020

Event Type  Injury  

Event Description

I realize that my husband and i are getting sick because of the sleep 8 cpap cleaning machine.Our throats, sinuses and chests are irritated and congested since i have been using this cleaning device.We do not have fevers.I have followed all directions and was not told this machine was not fda approved and nor that it caused irritation and illness like this.I called my doctor's emergency exchange and they advised the manufacturer has to tell me how to treat myself for the exposure.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: 10092974
• MDR Text Key: 192227390
• Report Number: MW5094696
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 6022400263
• UDI-Public: 6022400263
• 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: 05/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• 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: 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): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 75