MAUDE Adverse Event Report: PHILIPS / RESPIRONICS INC. PHILIPS CPAP SLEEP APNEA DEVICE; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number SYSTEM ONE HTD HUMID,DOM

Device Problems Nonstandard Device (1420); Device Emits Odor (1425)

Patient Problem Insufficient Information (4580)

Event Date 08/25/2021

Event Type  malfunction  

Event Description

Cpap machine recall no action to date.Now machine is giving out a terrible odor.Not healthy.Room and my body smells.How bad is this for my lungs? where do i go for advice?.Fda safety report id # (b)(4).

• Brand Name: PHILIPS CPAP SLEEP APNEA DEVICE
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 13445912
• MDR Text Key: 285159247
• Report Number: MW5107189
• Device Sequence Number: 1
• Product Code: MNS
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SYSTEM ONE HTD HUMID,DOM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2022
• Patient Sequence Number: 1
• Treatment: CARVEDILOL ; ELIQUIS ; PRAVASTATIN; SPIRONOLACTONE
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White