MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. SOCLEAN; DISINFECTANT, MEDICAL DEVICES

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Cough (4457)

Event Date 10/01/2020

Event Type  Injury  

Event Description

Persistent morning cough; i switched to a sleep apnea machine from philips in (b)(6) 2019.After using for about a year, i developed a morning cough with lots of congestion.I believe it is related to a defect in the sleep apnea machine with the sound abatement foam that i inhaled and the off-gas chemicals from the use of the so-clean machine.There is no explanation for the cough that my doctor could find without costly further testing.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12615922
• MDR Text Key: 276238366
• Report Number: MW5104533
• 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: 10/06/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 129