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

Model Number	CAX400H12C
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.There was no report of patient harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
Additional information was received on sep 08, 2023 and section h11 should be reported as: the manufacturer was 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 manufacturer previously received information alleging headaches, lightheaded and black residue in chamber and mask related to a cpap device's sound abatement foam.There was no report of patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.During an exterior investigation, the manufacturer observed that there was unknown dust/dirt contamination present on all surfaces of the base unit.The device did not return with an sd (secure digital) card or filter.There was an unknown dust contaminate present at the air inlet where the filter would be.There is unknown dust/dirt particle contamination observed at the iso (international organization for standardization) port entrance.During an interior investigation, the manufacturer observed that there was unknown debris in the tracks of the ui (user interface) panel.There was an unknown white dust contamination found on the bottom enclosure, blower box housing, blower motor, and blower impeller.A keratin-like substance was observed near the blower box housing outlet.Evidence of sound abatement foam degradation/breakdown was not observed in the base unit.The secondary findings were observed that a keratin-like substance was observed around the blower box outlet.The unknown dust/dirt contamination and fibers found on the blower casing/impeller and blower box was inconsistent with degraded sound abatement foam contamination.The presence of contamination throughout the airpath suggests a source external to the device.The manufacturer used a fitt (foam integrity test tool) and was not able to confirm the presence of degraded sound abatement foam.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found no error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes that there was no evidence of sound abatement foam degradation.The manufacturer confirmed the presence of contamination in the airpath and unable to address the patient's symptoms.Sections d9, h2, h3 and h6 has been updated 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: rosko melissa ; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 12733532
• Report Number: 2518422-2021-06104
• Device Sequence Number: 4559922
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2018
• 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