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

Model Number DSX520H11C

Device Problems Device Emits Odor (1425); Smoking (1585); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2023

Event Type  malfunction  

Manufacturer Narrative

Device has not been returned for investigation.

Event Description

The manufacturer became aware that a user of a dreamstation2 cpap device alleged that when he powered his device on, it started to smoke behind the humidifier on the device.The user also alleges that there was a plastic burning smell and there was sparking.There was no report of flames, no melting, warping or voids on the device enclosure.The device was plugged directly into the wall outlet.The user states when the heated humidifier was taken off, the smoke comes out.There was no report of patient harm or injury.The device has been replaced for the user.The product has not been returned for investigation.The manufacturer's investigation is on-going.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: DREAMSTATION2 ADV. AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18479384
• MDR Text Key: 332882835
• Report Number: 2518422-2024-01508
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520H11C
• Device Catalogue Number: DSX520H11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male