MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN MACHINE; DISINFECTANT, MEDICAL DEVICES

Device Problems Degraded (1153); Nonstandard Device (1420); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

I have noticed the water getting blackish in the water chamber of my philips dreammachine cpap device but did not think it was a problem until i received the recall on my device.I have been using the soclean daily for sanitation and was also regularly cleaning the water chamber and replacing the filters as recommended.Philips is blaming the degradation of the sound abatement foam on the use of the soclean machine and soclean is blaming it on philips for using an inferior foam product.My doctor says that i still need to use a cpap, but my medical supply company says that there is a shortage of them and they are unable to provide one for me.Philips indicates that they are working on the problem but expect the process of replacing and/or repairing the devices will take 12 months.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN MACHINE
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12672495
• MDR Text Key: 278081772
• Report Number: MW5104813
• 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: 10/18/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• 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