MAUDE Adverse Event Report: OZONE CLEANERS DISINFECTANT, MEDICAL DEVICES

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Asthma (1726); Dyspnea (1816); Forced Expiratory Volume Decreased (2430)

Event Date 06/16/2021

Event Type  Injury  

Event Description

I was diagnosed with asthma and prescribed flovent and albuterol inhalers. I have never had respiratory problems in my life. I was notified by respironics that the cpap machine i was using, dreamstation, was recalled due to a foam within the machine for sound abatement degrading and being released into the air pathway and can be inhaled. It may be exacerbated by use of ozone cleaners which i used for about 3 months. One of the side effects is irritation of the respiratory tract, cough, and asthma. I began having shortness of breath with exercise and difficulty exhaling. I do have a congenital heart defect and have had surgery. But my cardiologist has performed tests and determined that these symptoms were not heart related. I had pulmonary function tests done and it was abnormal. My expiratory volume/pressure was abnormal. I am followed by a pulmonologist. The cpap machine has helped very much with my sleep as i used to wake up with headaches every day. However i am afraid to continue using it. I feel it could be contributing to my respiratory problems. There is moderate decrease in fev1 and fvc with normal tlc suggesting a moderate obstructive ventilatory defect. Normal diffusion capacity and non specific airway resistance pattern is notes. Fda safety report id # (b)(4).

• Brand Name: OZONE CLEANERS
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• MDR Report Key: 12481008
• MDR Text Key: 272118836
• Report Number: MW5103986
• Device Sequence Number: 2
• Product Code: LRJ
• 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: 09/13/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• 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 Answer provided

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: 09/15/2021 Patient Sequence Number: 1