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

Model Number	CAX400H12C
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a batch submission of complaints that were reassessed as reportable foam degradation complaints; discovered as part of a retrospective remediation review.
Event or Problem Description
The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient was not using the device at the time of event.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer was previously contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap/ bipap, and mechanical ventilator devices.The patient alleged the power port was burnt.There was no report of patient harm or injury.The device was returned to the manufacturer for investigation.During the evaluation of the device, the manufacturer visually inspected the device and confirmed there was evidence of discoloration found to the dc power supply, dc output connector and the dreamstation dc input power connector (p4) that is found to be rust/corrosion damage as a result of the water ingress to the power connectors.The product investigation lab could not confirm the complaint about the unit getting hot and found no evidence of thermal damage.The product investigation lab used a well-known power supply and p4 connector and applied power to the dreamstation/humidifier.The product investigation lab verified the unit has power, provides flow, and the humidifier heater plate/heated tubing functions.An internal inspection of the dreamstation found more evidence of the water ingress and corrosion to the dc volt input connector (p4) and staining to the bottom enclosure also indicative of water ingress.There is evidence of dirt/dust contaminants found in the dreamstation air inlet filters.The product investigation lab found no evidence of the chamber leaking.The product investigation lab confirms the complaint is found to be caused by water/liquid ingress to the dc input power connector (p4) of the dreamstation base unit and to the dc power supply output connector.The finding of water ingress to the dreamstation blower box assembly indicates the unit was moved or mishandled while there was still water in the chamber of the associated humidifier (a leaky chamber would not have resulted in water ingress to the dreamstation blower).The dreamstation cpap user manual notes in the "warnings" section: if you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if it has been dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, disconnect the power cord and discontinue use.Contact your home care provider.Additionally, the dreamstation humid, user manual notes in the "warnings" section: periodically inspect the humidifier for signs of wear or damage.Never operate the humidifier if any parts are damaged, if it is not working properly, or if the humidifier has been dropped or mishandled.Do not use the humidifier if the water tank is leaking or damaged in any way.Have any damaged parts replaced before continuing use.The "cautions" section of the humidifier manual also notes: remove the tank, empty all water, and replace the empty tank before transporting the humidifier base.There was no mention of foam degradation or particles being observed during the evaluation.The unit was scrapped.The manufacturer has updated h6 in this report.

• Brand Name: DREAMSTATION CPAP PRO
• 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 ; 7243512041
• MDR Report Key: 13869878
• Report Number: 2518422-2022-11111
• Device Sequence Number: 12080209
• Product Code: BZD
• UDI-Device Identifier: 00606959034501
• UDI-Public: 00606959034501
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2025

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: CAX400H12C
• Device Catalogue Number: CAX400H12C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2019
• 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
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Patient Sex: Unknown