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U.S. Department of Health and Human Services


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Device Problems Contamination (1120); Device Emits Odor (1425); Output Problem (3005)
Patient Problems Bronchitis (1752); Hyperglycemia (1905); Unspecified Infection (1930); Cough (4457)
Event Type  Injury  
Event Description
Pt states that about 5 years ago, in (b)(6) 2016, she was placed on a cpap machine. Pt reports that her husband bought a soclean device to clean the cpap. Pt notes immediately after plugging it in, it emits a horrendous odor. Pt states that she followed all the directions and used the device faithfully everyday and notes that the emitted from the machine permeated through the whole room. She notes that despite use of scent plug ins and opening the door to air the room, the smell lingers. Pt states that the odor has changed the smell of the room and the whole house. Pt reports concern that the odor emitted is not a normal occurrence. Additionally, pt reports developing worsening sinuses and lung complications as a result of prolonged use. Pt states constant sinus infections , bronchitis, a horrible cough, now notes a permanent horrible smell in her nose that she states she can't get rid of. Pt also reports having increased asthma attacks, lung issues and the constant use of antibiotics and allergy medications to combat illnesses. Of note, pt stated that after opening up the cpacp machine to clean it and change water reservoir, she noted black mold and had to manually clean device. Pt notes concern that the soclean device was to meant to prevent manual cleaning of the cpap. Pt notes that she spoke with her doctors about the use of the cpap and soclean device and was informed that she is doing everything correctly. Pt reports concern that despite correct usage she is having progressively worsening health complications. Pt states that she is currently concerned with her worsening sinus and lung issues as well as the seemingly permanent odor left in her nose. Pt states that her health issues have gotten severe and prevent her function normally. Pt states that as a diabetic these health complications increase her sugar levels. Pt reports at present she has been 1 week without her cpap machine. Pt alleges speaking with the supplier who told her not to use the cpap machine and wait for a replacement device due to the black mold.
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Manufacturer (Section D)
MDR Report Key12032826
MDR Text Key257897030
Report NumberMW5101991
Device Sequence Number1
Product Code LRJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/17/2021 Patient Sequence Number: 1