MAUDE Adverse Event Report: UNKNOWN RESPIFY CPAP OZONE CLEANER RESPIFY; DISINFECTANT, MEDICAL DEVICES

Model Number RESP2019

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 12/02/2020

Event Type  Injury  

Event Description

In 6 months ago purchased a respify ozone cpap cleaner.Used it every 3 weeks to clean the machine.After a couple of times i got a sore throat.So started to use a cpap humidifier and still clean with respify cleaner.Sore throat continued.Changed back to not using humidifier.Still have sore throat.Will be going to doctor soon.Something not right.(b)(6) hr manager retired flushing, mi r: (b)(6) end.Lists is too big, will e-mail it to you if requested.Fda safety report id # (b)(4).

• Brand Name: RESPIFY CPAP OZONE CLEANER RESPIFY
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10983460
• MDR Text Key: 220977907
• Report Number: MW5098301
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): Y
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RESP2019
• 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): Other
• Patient Age: 67 YR
• Patient Weight: 122