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

Model Number DSX520H11C

Device Problems Display or Visual Feedback Problem (1184); Fluid/Blood Leak (1250); Moisture or Humidity Problem (2986)

Patient Problems Sore Throat (2396); Respiratory Tract Infection (2420); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 02/07/2022

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned.

Event Description

The manufacturer became aware of allegations, that a dreamstation 2 spilling water every night when the user fills it up, screen is little and hard to operate, and she keeps running out of water while using this device.The user is also stated that her filters on her old dream station turned black a couple times.Additionally, user alleged that she had repeated sinus infections.She started with coughing, sore throat and blowing her nose of green stuff.The user's physician recommended antibiotics and a balloon surgery on her sinus.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.

• Brand Name: DS2ADV AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18101781
• MDR Text Key: 327733172
• Report Number: 2518422-2023-29285
• 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: 11/09/2023
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 02/07/2022
• Date Device Manufactured: 12/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female