MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC. CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cough (4457); Unspecified Respiratory Problem (4464)

Event Type  Injury  

Event Description

Started using soclean device with my philips respironics cpap and shortly after started a chronic cough and nasal problems.Been diagnosed with bronchiectasis.Fda safety report id # (b)(4).

• Brand Name: CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 15322013
• MDR Text Key: 298984161
• Report Number: MW5111786
• Device Sequence Number: 2
• Product Code: LRJ
• Combination Product (y/n): N
• 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: 08/26/2022
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2022
• Patient Sequence Number: 1
• Treatment: LOSARTAN; PANAPORASIL ; POTASSIUM; PREMARIN; SPIRONOLACTONE; SYNTHROID; VITAMIN D
• Patient Outcome(s): Disability
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White