MAUDE Adverse Event Report: PRIME CLEAN PORTABLE CPAP SANITIZER DISINFECTOR; DISINFECTANT, MEDICAL DEVICES

Model Number HET-N104

Device Problem Device Emits Odor (1425)

Patient Problems Syncope (1610); Dyspnea (1816); Chest Tightness/Pressure (2463); No Code Available (3191)

Event Date 06/19/2020

Event Type  Injury  

Event Description

I purchased a primeclean cpap cleaner and sanitizer from (b)(6).After all the research i did i still was not aware of the dangers of the use of ozone as a cleaner or understood what it would do.I have copd asthma and sleep apnea and use a bi-pap machine.After charging up the cleaner as directed and putting my hose and head gear and water chamber into the supplied bag and making sure it was tightly zipped closed, i turned on the machine and almost immediately felt faint, had a rushing feeling in my arms, legs and head.Within about 1 1/2 minutes my chest became tight and found it very difficult to breathe.The smell from the machine is sickening.I took the unit outside to function in outside air as the entire room had a very sickening smell.I then went to my computer to look this up and came upon your article about "cpap machines using ozone gas".That was at 8:30 am this morning.It is 6:45 pm now and the house still smells from the machine.The room i started it in had 2 open doors and is about 192 sq.Ft in size.I threw my tube, water chamber and hose in the trash around 5:15 pm and now my trash bin reeks of the smell.Fda safety report id # (b)(4).

• Brand Name: PORTABLE CPAP SANITIZER DISINFECTOR
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): PRIME CLEAN; 11222 s. lacienega blvd ; #500; inglewood CA 90302
• MDR Report Key: 10189285
• MDR Text Key: 196456885
• Report Number: MW5095177
• 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: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HET-N104
• 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