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

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

Patient Problems Dyspnea (1816); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/04/2021

Event Type  malfunction  

Event Description

In 2018 lung x-ray for shortness of breath.No issues found with the lungs, all items checked healthy.In 2019 cpap in use.In 2021 lung x-ray for low co2, starving for air, lung spasms.X-ray results, lung scarring detected, lung node detected.Awaiting cat scan for better lung views.Recalled cpap machine began overtime with use to get loud.Breathing got harder and lung irritation grew more evident.Sought treatment from my (b)(6) doctor.Received a filter to apply to the cpap hose to catch particles.Did find small smudge particle that smeared like ash inside of the unit.Concerned that the bad philips cpap has caused damage to my lungs after 2018 and up to 2021.Never a smoker, no prior history of lung damage until using the cpap machine.My (b)(6) doctor thinks i now need it more than the risk of not using it.I fill the risk is too late and the damage has been done.Breather is labored all the time now and i believe the cat scan will confirm scaring on the outer protective lung tissue and a possible particle node of 3 to 4 cm will be confirmed.Cannot determine any other reason except the continued use of the cpap machine from 2019 to 2021 and the failure of the foam insert during this two year period.Registered with philips, sn (b)(4) dreamstation.Which is on the recall list.Decorated veteran (b)(6); 100% fully disabled.All care provided by the (b)(6).A great hospital; (b)(6) just want this registered in case others have this same kind of issue with the machine.Saturation test was range taken from (b)(6) 2021.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12682059
• MDR Text Key: 278342606
• Report Number: MW5104873
• Device Sequence Number: 1
• Product Code: BZD
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 102