MAUDE Adverse Event Report: OZONE CLEANER; DISINFECTANT, MEDICAL DEVICES

Device Problems Contamination (1120); Nonstandard Device (1420); Particulates (1451); Patient-Device Incompatibility (2682)

Patient Problems Hypoxia (1918); Pneumonia (2011); Respiratory Tract Infection (2420); Respiratory Failure (2484)

Event Type  Injury  

Event Description

Following an acute respiratory infection, i found out my cpap was on recall.I was instructed to discontinue use as i had used an ozone cleaner which resulted in black deposits on filter.I ended up in intensive care on 8 liters of oxygen and viral pneumonia with acute respiratory failure and hypoxia sent home on oxygen, and now on medication to breathe.Ever since i started using the dream station i began to suffer from recurring respiratory infections, i told my pc that i felt it was the machine that was the culprit, i used an ozone cleaner out of desperation as i thought it might be dirty and was causing me to be sick, i started using the cleaner and was setting a black discharge on my filter which i mistakenly thought was dirt or mold as i have a heated humidifier on the unit.I still was having irritation and started using albuterol to alleviate my symptoms.My last infection was in (b)(6) 2021 that is when i found out about the recall of this machine.Philips told me to stop using it, my infection progressed into acute respiratory failure and hospitalization before i could see my sleep apnea doctor.I now have damage to my respiratory system as well as copd.My machine was one month short of being 5 years old.

• Brand Name: OZONE CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• MDR Report Key: 12598266
• MDR Text Key: 275894157
• Report Number: MW5104472
• 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: 09/29/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 61 YR
• Patient Weight: 61