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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Rash (2033); Discomfort (2330)

Event Date 04/23/2020

Event Type  Injury  

Event Description

I've been using o zone based sanitizing system for cpap under the brand name "sleep 8".Have had breathing problems including wheezing and stinging when inhaling following use of the sleep 8 system.Do not present these symptoms when i just wash the cpap system with soap and water per manufacturer instructions.I have also developed a rash around where my mask contacts my face.Fda safety report id# (b)(4).

• Brand Name: SLEEP 8
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• MDR Report Key: 10005062
• MDR Text Key: 189350165
• Report Number: MW5094288
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 181