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

Model Number DSX520H11C

Device Problem Insufficient Heating (1287)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer became aware of an allegation of ds2adv auto cpap, that the patient states that the water level is just under the max line; and the warming plate was cold to touch after being on for 15 minutes.The patient alleges having to stop using the device after the discomfort of dried out sinus, and throat and lung irritation.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 W/HUMID CELL/BT
• 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: 18549385
• MDR Text Key: 333318407
• Report Number: 2518422-2024-03663
• 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: DSX520H11C
• Device Catalogue Number: DSX520H11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1