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

Model Number DSX520T11C

Device Problem No Apparent Adverse Event (3189)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

Event Description

The manufacturer became aware that a user of the dreamstation 2 advanced auto cpap had states he saw a black particle in the humidifier.Patient also states that he cleans the mask every day and changed filter monthly.There was no report of serious patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: DS2ADV 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: 18833069
• MDR Text Key: 336881060
• Report Number: 2518422-2024-11439
• 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

• 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: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1