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

Device Problem Degraded (1153)

Patient Problems Dizziness (2194); Cough (4457); Unspecified Ear or Labyrinth Problem (4474)

Event Date 07/03/2021

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

Event Description

The manufacturer received a voluntary medwatch (mw5102358) in reference to the field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging the patient stated, "i live in a humid climate and have been using the philips dreamstation cpap machine since 2016.In a normal follow-up visit for pft with my pulmonologist i had complained of dizziness, cough, and what felt like a sinus infection.I had no fever but some of these symptoms persisted for quite some time (even years before) off and on.Most recently had been feeling fatigued even with normal cpap use.He said after examining i had blood on top of my done in both ears and gave me a zpack.The next morning, i actually called the office and asked the staff again if there was any way to clean the inside pipes of the unit as i suspected it could be something trapped inside.I'm on day two of meds, still dry cough, some breathing issues, and dizziness.Last night i was told by a friend that i should look into the recall as he heard it could cause lung cancer".The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: DREAMSTATION PHILIPS CPAP DEVICE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17650034
• MDR Text Key: 322272472
• Report Number: 2518422-2023-21244
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening