MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN FAMILY OF PRODUCTS; DISINFECTANT, MEDICAL DEVICES

Model Number

Device Problems Nonstandard Device (1420); Device Contamination with Chemical or Other Material (2944)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/16/2021

Event Type  Injury  

Event Description

I use a philips dreamstation cpap that has been registered and confirmed to be part of recall.I had noticed fine black particles in water reservoir before recall which i thought were mold.I stepped up my cleaning procedures and made sure i used the soclean ozone cleaner every day.Which only made it worse.When i learned about recall (through newspaper) in august, since i could not sleep without the cpap, i added a bio filter at drs recommendation and stopped using the soclean.I have been waking up with headaches frequently and when i checked the bio filter last night to change it, it was very gray compared to a new filter.I have stopped using the cpap.I have called phillips twice in the last six weeks to check on progress of recall and i've never heard anything from them.I informed them that my foam had begun decomposing and asked for them to expedite a rework for me.I am concerned about what i may have breathed into my lungs if the bio filter was not adequately filtering the particles.I will contact my doctor right away about this.When i had a sleep study 3 years ago, the study had to be discontinued because my oxygen level had fallen to 73 for a period of time.I had over 55 ahis during rem phase and was given a stat order for a cpap machine that day.I have used the cpap every night all night since then and it has been a life saver.When i found out about the recall, i stopped using it for 2 nights and just could not sleep.I had to go back to using it but added the bio filter, hoping that would stop any particles.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN FAMILY OF PRODUCTS
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12506637
• MDR Text Key: 272699187
• Report Number: MW5104087
• 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: 09/17/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient

Device Model Number

• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 63 YR
• Patient Weight: 93