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

Device Problems Nonstandard Device (1420); Patient Device Interaction Problem (4001)

Patient Problems Chest Pain (1776); Emotional Changes (1831); Cough (4457); Unspecified Respiratory Problem (4464)

Event Type  Injury  

Event Description

Dreamstation cpap machine is under recall.I have been noticing upper airway irritation, coughing and occasional chest pressure, all after a nights use.I thought nothing about it until i received a recall notice and symptoms involved.These symptoms coincide with using this faulty device.I have never had these symptoms prior to using this device.It all makes sense to me now.I am nervous about any possible damage to my health.What are my next steps? i have registered my device on the philips website.Will be contacting the prescribing doctor for my device as well.My understanding is that philips does not have a replacement device at this time.What else do i do from here? thank you in advance for help and advice.Fda safety report id # (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 12820514
• MDR Text Key: 280893788
• Report Number: MW5105346
• 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: 11/11/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2021
• Patient Sequence Number: 1
• Treatment: NEFEDIPINE( 30MG BLOOD PRESSURE)
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White