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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TIANCHANG TIANHE OPTOELECTRONICS TECHNOLOGY CO., LTD., RESCARE CPAP CLEANER; DISINFECTANT, MEDICAL DEVICES
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TIANCHANG TIANHE OPTOELECTRONICS TECHNOLOGY CO., LTD., RESCARE CPAP CLEANER; DISINFECTANT, MEDICAL DEVICES Back to Search Results
Model Number CR2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Dyspnea (1816)
Event Date 10/01/2020
Event Type  Injury  
Event Description
Bought a ozone cpap cleaner on (b)(6).After i started using it, i started gasping for breath 20 to 40 times a day, went to the doctor who sent me for ekg, echo stress test, chest x-rays, to see a pulmonologist and get a breathing test.All test came back just fine.Breathing started getting better with less gas being only 5 to 10 times a day.I eventually was going down to two to five times and feeling much better, and then use the ozone generator again and started cleaning first time i used it for a few months, and my breathing got bad again and went up to the original high numbers of gasping.Fda safety report id # (b)(4).
 
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Brand Name
RESCARE CPAP CLEANER
Type of Device
DISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
TIANCHANG TIANHE OPTOELECTRONICS TECHNOLOGY CO., LTD.,
shouchang east road, qinlan town,anhui province
tianchang city
CH 
MDR Report Key11139188
MDR Text Key226278100
Report NumberMW5098735
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCR2
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/07/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age60 YR
Patient Weight84
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