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: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Weight: 54