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

Model Number UDSX500S11F

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Headache (1880); Nausea (1970)

Event Date 10/10/2023

Event Type  Injury  

Event Description

The manufacturer received information alleging the weird smell coming from dreamstation auto cpap device.Patient stated that the smell made her sick, she got a headache and nausea from the odor.She stated the smell is foul and causes her face to feel itchy.Resolution : rt and patient reviewed the cleaning method.Patient stated that she cleans with soap and water, rinse and air dry, and repeats every 4-5 days.Advised the patient to be sure to clean daily with the same method.Rt advised the patient to remove the filters and observe them.Patient stated that the filters are brand new, fine and clean.

• Brand Name: DREAMSTATION 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: 18094594
• MDR Text Key: 327660829
• Report Number: 2518422-2023-29497
• 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: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UDSX500S11F
• Device Catalogue Number: UDSX500S11F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 54 YR
• Patient Sex: Male