MAUDE Adverse Event Report: PHILIPS RESPIRONICS DREAMSTATION; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX 500T11C

Device Problems Nonstandard Device (1420); Particulates (1451)

Patient Problems Chest Pain (1776); Dyspnea (1816); Headache (1880); Nausea (1970); Dizziness (2194); Sore Throat (2396); Eye Pain (4467)

Event Date 09/02/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, i began having headaches, nausea, and dizziness.Headache so bad i took an aspirin one day, even though i am not "supposed" to, due to kidney disease.After a few days, nausea went away, however my eyes were very irritated and continued to have headaches and dizziness occurring daily.Around the (b)(6).Symptoms continued, my throat was scratchy, and i began feeling chest pressure and had difficulty breathing, i have copd, asthma and heart disease so called my doctor and she prescribed proair and use nebulizer as needed to see if those helped.Today while cleaning dreamstation cpap machine noticed black specks.I knew there was a recall on dreamstation machines, so i looked at it more closely, checked to see if my machine was part of the recall, it is, and now strongly suspect my dreamstation cpap machine is causing the health problems i am having.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS RESPIRONICS
• MDR Report Key: 12475455
• MDR Text Key: 271892536
• Report Number: MW5103958
• Device Sequence Number: 1
• Product Code: MNS
• 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: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX 500T11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR