MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION 2 ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	BLX520H15C
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	12/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information regarding a dreamstation 2 adv auto cpap device.The patient states "the water tank is empty in the morning", the humidifier continues to heat after the water has evaporated, a burning smell, "heating [is] out of order", and "the heater is becoming quite warm." they have been using this new device for a few weeks now and had "sent the first one back to [the dme] because the heating often did not work" and "kept the reservoir filled to the brim with water".On the night of dec-02-2023, "all the water evaporated" and it was "the first time a defect has occurred with this second [device]." the patient alleges their lungs were sore, irritation with their mucous membranes, and "felt a rush of cold air" when they woke up in the morning.The humidity in the bedroom "was about 69% during the night" when they "measured this with a scientific humidity meter" which they state, "this implies that the pressure switch of the heating element was functioning." in addition, the patient states "the heating continued to heat appears to be because it did not go out at the set point." they are concerned "not so much that the reservoir will become dry, but whether the water can boil." there was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported information in reference to a dream station 2 adv auto cpap device.The patient alleged the humidifier continues to heat after the water has evaporated, a burning smell, "heating [is] out of order", and "the heater is becoming quite warm.This notification was opened for review for information received that a humidifier continues to heat after the water has evaporated, a burning smell, "heating [is] out of order", and "the heater is becoming quite warm.No death.No serious harm or injury was reported.Analysis of past events has not indicated an adverse event has occurred due to the reported allegation or would be likely to recur if the product allegation was to recur.In addition, a review of the risk file indicates the potential for a serious adverse event occurring as a result of this incident is unlikely.This event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury and/or reportable product malfunction.

• Brand Name: DREAMSTATION 2 ADV AUTO CPAP
• Common Device Name: 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18540327
• Report Number: 2518422-2024-03428
• Device Sequence Number: 12725760
• Product Code: BZD
• UDI-Device Identifier: 00606959062818
• UDI-Public: 00606959062818
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K200480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: BLX520H15C
• Device Catalogue Number: BLX520H15C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown