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

Model Number DSX700S11F

Patient Problems Chest Pain (1776); Dyspnea (1816); Muscle Weakness (1967); Dizziness (2194); Respiratory Tract Infection (2420); Confusion/ Disorientation (2553)

Event Date 04/17/2024

Event Type  Injury  

Event Description

I have a replacement philips bi-pap that has caused health issues from the time i got it.Since started using the new machine i have had sinus inflammation on a regular basis.I also suffered my first sinus infection that required two rounds of anti-biotics.I have been developing a shortness of breath over last few months (getting worse) and i have also recently started having sever chest pain (related to breathing) when doing physical exertion.On (b)(6) 2024 i woke up at 3:30am with difficulty clearing my sinuses and extreme shortness of breath.I was admitted to the emergency room about an hour later.I was experiencing extreme difficulty getting a full breath of air, weakness in my legs, dizziness and some disorientation.After they monitored me for a while and gave me prescription to relax me i was able to start breathing normally again.This has never happened before and we believe it is all due to the replacement philips bi-pap that i got as part of the overall recall.

• Brand Name: PHILIPS DREAMSTATION BI-PAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 19153601
• MDR Text Key: 340864800
• Report Number: MW5154057
• 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: 04/18/2024

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 Model Number: DSX700S11F
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Patient Sequence Number: 1
• Treatment: ALBUTEROL INHALER.; ASPRIN.; DILTIAZEM.; IBUPROFEN.; LISINOPRIL.; ROSUVASTATIN.
• Patient Outcome(s): Disability; Other; Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White