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

Model Number DREAMSTATION 2

Patient Problems Asthma (1726); Burning Sensation (2146); Sleep Dysfunction (2517)

Event Date 12/10/2023

Event Type  Injury  

Event Description

Woke with a burning sensation in my throat and lungs like they were being singed.I haven't been able to use the cpap properly since.It's like my lungs are wrestling with the machine.It's affecting my sleep, asthma and overall health.

• Brand Name: CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS / RESPIRONICS INC.
• MDR Report Key: 18781120
• MDR Text Key: 336335662
• Report Number: MW5151955
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DREAMSTATION 2
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability