MAUDE Adverse Event Report: SLEEP 8, INC SLEEP 8 CPAP SANITIZING COMPANION; CPAP CLEANER

Model Number SLP82043

Device Problem No Apparent Adverse Event (3189)

Patient Problem Discomfort (2330)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation and this report were completed within the appropriate time period, however, when attempting to initially submit this emdr we experienced technical difficulties that caused delay in the submission.Specifically, on june 3, 2019, while going through the web trader self-registration in the fda's esg test system we were informed by the esg help desk that our personal digital certificate expired in june of 2019 and that we would need to obtain another certificate with an expiration date between 1 and 3 years.On june 3, 2019, we applied for a new certificate meeting these requirements through (b)(4) but this process takes several business days, delaying our completion of the self-registration process and electronic submission of the non-adverse event mdr.On june 5, 2019, we notified the fda via emdr@fda.Hhs.Gov of these technical difficulties.On june 6, 2019, (b)(6) (fda consumer safety officer, mdr team) responded to our email and instructed that we include this summary regarding the technical difficulties so that this submission would not be considered late.Once the personal digital certificate issue was resolved and the self-registration completed, we updated this emdr as instructed by the fda mdr team and submitted on june 24, 2019.

Event Description

A medwatch report was filed anonymously on 4/22/2019.Sleep 8 became aware of the report through a 4/29/2019 letter issued by the fda.The anonymous reporter states that the anonymous reporter had used a "soclean8" and followed all instructions when cleaning a cpap.When using the cpap that evening, the anonymous reporter smelled "ozone odors." after about a 1/2 hour the anonymous reporter stopped using the cpap.The anonymous reporter states having strong coughing and burning in lungs and nasal passages.No other information was provided.There is no indication that the anonymous reporter experienced any further complications, including, a serious injury that would meet the definition under 21 c.F.R.803.3.

• Brand Name: SLEEP 8 CPAP SANITIZING COMPANION
• Type of Device: CPAP CLEANER
• Manufacturer (Section D): SLEEP 8, INC; 1569 mallory lane; bldg 100; brentwood TN 37027
• Manufacturer (Section G): SLEEP 8, INC; 1569 mallory lane; bldg 100; brentwood TN 37027
• Manufacturer Contact: jordan soblick ; 1569 mallory lane; bldg 100; brentwood, TN 37027 ; 5614410906
• MDR Report Key: 8729109
• MDR Text Key: 176014347
• Report Number: 3014439254-2019-00001
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SLP82043
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1