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

Model Number DSX520T11C

Device Problems Device Emits Odor (1425); Material Integrity Problem (2978)

Patient Problem Sleep Dysfunction (2517)

Event Date 03/04/2024

Event Type  malfunction  

Event Description

The manufacturer received a voluntary medwatch (mw-5152518) in which the patient alleges that have been burning smell and the tank dries up before the end of each night.Medical intervention was not included.The device has not yet been returned to the manufacturer for investigation.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 : device not returned to the manufacturer.

• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19149901
• MDR Text Key: 341050881
• Report Number: 2518422-2024-16250
• 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: Other,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: 03/25/2024
• Initial Date FDA Received: 04/20/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1