MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION 2 ADVANCED AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520T11C

Device Problem Device Emits Odor (1425)

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

Event Date 10/02/2023

Event Type  malfunction  

Manufacturer Narrative

Device serviced by a third-party service center.

Event Description

The manufacturer became aware that a user of the dreamstation 2 advanced auto cpap had states the patient had smelled burning smoke, the circuit was burned and nearly burned through the airpath.There was no serious patient harm or injury.No medical intervention was specified by the patient.  the manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: DREAMSTATION 2 ADVANCED 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: 18812642
• MDR Text Key: 336647162
• Report Number: 2518422-2024-10781
• 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: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520T11C
• Device Catalogue Number: DSX520T11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1