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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sore Throat (2396)

Event Date 05/01/2022

Event Type  Injury  

Event Description

Using so clean 2, machine to clean my cpap mask, head gear, hose, etc.Notice sore throat problem each morning after normal use, with philips respironics, cpap machine.I am waiting for a replacement machine from philips.Fda safety report id # (b)(4).

• Brand Name: CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 14376181
• MDR Text Key: 291623004
• Report Number: MW5109656
• 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: 05/09/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White