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

Model Number DSX200H11

Device Problems Device Emits Odor (1425); Insufficient Information (3190)

Patient Problems Headache (1880); Nausea (1970); Burning Sensation (2146); Dizziness (2194); Sore Throat (2396); Unspecified Respiratory Problem (4464)

Event Date 06/29/2021

Event Type  malfunction  

Event Description

The manufacturer received information regarding a dreamstation cpap with an allegation of a burning/smoke/electrical odor.The patient alleges a burning sensation in their nose, feeling like it is on fire, machine burned [their] nose and that it was not out of water [as they] made sure of it before [they] got the heating and tubing.In addition, the patient alleges a bad smell, bad headache, feeling sick, nausea and throwing, lightheadedness, dizziness, nasal/throat irritation and soreness after using the machine.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.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: DREAMSTATION 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: 18301988
• MDR Text Key: 330176530
• Report Number: 2518422-2023-32478
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• 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: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX200H11
• Device Catalogue Number: DSX200H11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/24/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1