MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION2; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520H11C

Patient Problems Cough (4457); Epistaxis (4458)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

Several months after receiving my philips cpap recall replacement unit, a dreamstation2 i was awakened by heavy smoke.I unplugged it, aired it out for a few days then plugged it back in.Now and then my room smells like burning dryer lint.It hasn't filled with smoke but does smell.As soon as i started getting a bloody nose and constant cough i unplugged it and bought a resmed unit.

• Brand Name: DREAMSTATION2
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 18780828
• MDR Text Key: 336322571
• Report Number: MW5151950
• 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: 02/10/2024

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520H11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Race: White