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

Device Problems Particulates (1451); Unexpected Shutdown (4019)

Patient Problems Aspiration/Inhalation (1725); Cough (4457)

Event Date 11/01/2022

Event Type  Injury  

Event Description

I use cpap machine daily.White plastic particles have been seen in resmed humidifier.I may have also inhaled into my lungs some of these particles and have developed cough that still persists today.I have collected these small particles from the humidifier that has come up until today.I did have a chest xray done on (b)(6) 2022 but (b)(6) did not find anything.I am coughing daily.I reported the issue to resmed local dealer but they referred me back to (b)(6) to buy a new unit.I also contacted resmed but they told me to go back to dealer.So i am seeking assistance from fda.This machine was replaced in (b)(6)2022 for not functioning well.Will stop in the night and needed to be restarted again.

• Brand Name: RESMED CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 16122331
• MDR Text Key: 307010603
• Report Number: MW5114224
• Device Sequence Number: 1
• Product Code: BZD
• 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: 01/04/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; LISINOPRIL
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander