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

Model Number SLP82043

Patient Problems Headache (1880); Respiratory Distress Syndrome of Newborns (2046); Cough (4457)

Event Date 07/15/2023

Event Type  malfunction  

Event Description

Used the sleep 8 ozone cleaner and did not wait awhile before using the cpap tubing and mask.Woke up in severe respiratory distress with a deep painful cough and headache which lasted a few hours.I was able to breathe better after a half hour of awakening.It scared me a lot.I do not have any other respiratory issues other than sleep apnea.

• Brand Name: SLEEP 8
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): SLEEP 8, INC.
• MDR Report Key: 17550902
• MDR Text Key: 321284029
• Report Number: MW5144567
• 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: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SLP82043
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2023
• Patient Sequence Number: 1
• Treatment: CPAP.
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White