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

Model Number SLP82043

Device Problem Device Emits Odor (1425)

Patient Problem Burning Sensation (2146)

Event Date 03/29/2019

Event Type  Injury  

Event Description

Used a soclean8 cpap cleaner, followed directions for use completely.Started to use my cpap that night, unit had a high level ozone odors present.After about 1/2 hr i had to discontinue using the machine.I had very strong coughing and burning in my lungs and nasal passages.Never had any problems with cpap machine before.Fda safety report id# (b)(4).

• Brand Name: SLEEP 8 TRAVEL CPAP CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SLEEP 8 INC.
• MDR Report Key: 8544681
• MDR Text Key: 143027084
• Report Number: MW5086082
• Device Sequence Number: 0
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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 Age: 73 YR
• Patient Weight: 93