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

Model Number DREAMSTATIONAUTOBIPAPHUMHT DOM

Device Problem Nonstandard Device (1420)

Patient Problems Asthma (1726); Dyspnea (1816); Sleep Dysfunction (2517)

Event Date 01/15/2018

Event Type  Injury  

Event Description

I started to have severe asthma attacks that prevented me from sleeping.As soon as i nodded off, the attack woke me up gasping for air in a violent manner.This is repeated throughout the night.After seeing my doctor, he confirmed that i have developed asthma and prescribed medication and inhaler.I have been using them since then, but sometimes it does not work.I just learned recently that philips respironics has had a recall of the bi-level pap machine that i have been using for years.From their recall letter, they advised that i can registered for adverse reaction at this fda site.My primary doctor just passed away in (b)(6) 2021.I cannot recall or get information about any lab test shortly after the first asthma incident in (b)(6) 2018.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS BI-LEVEL PAP MACHINE DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12804128
• MDR Text Key: 280807240
• Report Number: MW5105272
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00606959022546
• UDI-Public: (01)00606959022546
• 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: 11/08/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DREAMSTATIONAUTOBIPAPHUMHT DOM
• Device Catalogue Number: DSX700T11
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Other
• Patient Sex: Male