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

Model Number DSX500H11C

Device Problem Output Problem (3005)

Patient Problems Respiratory Tract Infection (2420); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/01/2020

Event Type  malfunction  

Event Description

Increased frequency of nasal congestion and sinus pressure not related to upper respiratory infections or allergies.Received notice from philips around 2021 that my dreamstation cpap machine had problems with the sound abatement foam degradation and organic compound emission.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13634514
• MDR Text Key: 286498217
• Report Number: MW5107785
• 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: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/06/2020
• Device Model Number: DSX500H11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN 10MG; FISH OIL ; GLUCOSAMINE; LOSARTAN 100MG; SOCLEAN 2; VITAMIN B6; VITAMIN D
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Hispanic
• Patient Race: White