MAUDE Adverse Event Report: RESPIRONICS, INC. DS2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RSPATEIROR)

Model Number DSX520T11C

Device Problems Failure to Conduct (1114); Failure to Power Up (1476); Smoking (1585)

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

Event Date 01/20/2024

Event Type  malfunction  

Event Description

The user of a dreamstation 2 advanced contacted the manufacturer in reference to their device smelling like burning electrical wires and visualizing smoke coming from the device (the humidifier).The patient did not see flames and there is no evidence of melting, warping or voids/gaps in the enclosure.There is not allegation of harm or serious injury.No clinical information or medical intervention was specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : the device has not been returned to the manufacturer for analysis.

• Brand Name: DS2ADV AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RSPATEIROR)
• 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: 18891593
• MDR Text Key: 337517473
• Report Number: 2518422-2024-13589
• 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
• 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: 03/12/2024
• 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
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male