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

Model Number DSX500S11F

Device Problems Material Disintegration (1177); Device Emits Odor (1425)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2023

Event Type  malfunction  

Event Description

The manufacturer received information regarding a dreamstation auto cpap.The patient alleges that while on vacation, the device had a "burning, horrible smell".The patient noticed black particles in the water chamber and tubing (but not the mask) beginning (b)(6) 2023.The patient stated this event was getting progressively worse each day.The patient cleaned the water chamber and tubing with a cleaning suspension called control 3 disinfectant germicide, placing a cap full in water.The patient soaked the tubing daily and the water chamber every three days.The patient cleaned the mask daily with cpap spray.The patient alleges the filters have nothing except daily household dust on them.The patient used both reusable and disposable filters.The patient rinsed the reusable filters with plain water monthly and changes the reusable filter every six months.The patient changed the disposable filter every two weeks.The patient drove and the device was in its carrier case.The patient did not use the device prior to the vacation.There was no report of flames, smoking, burning, melting or warping.The patient is not a smoker, nor is any household member a smoker.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• 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: 18672730
• MDR Text Key: 335712934
• Report Number: 2518422-2024-06289
• 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: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500S11F
• Device Catalogue Number: DSX500S11F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female