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

Model Number	CAX400H12
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop cancer.There is no report of the medical intervention that the patient has received at this time.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 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 caused a patient to develop cancer related to a cpap device's sound abatement foam.There was no report of patient harm or injury.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 was updated in this report.
Additional Manufacturer Narrative
The dreamstation cpap pro device was returned to the manufacturer's product investigation lab (pil) for further evaluation.The device powered on, and the airflow was confirmed.The service center retrieved and reviewed the device's error logs.There were 2 errors found.The device was inspected externally and internally.A sticky tapelike substance was observed on the top enclosure.A dust like contaminant was also observed on the top enclosure, keypad, control dial, user interface panel, rear panel, bottom enclosure, printed circuit assembly, blower motor, and blower box.A keratin-like substance was observed on the blower box outlet.During the evaluation, evidence of sound abatement foam degradation/breakdown was not observed.Pil used a fitt (foam integrity test tool) and the associated procedure and was unable confirm the presence of degraded sound abatement foam.The philips pil engineer could not confirm the customer's allegation and there was no visible foam degradation.Sections d9, g1, h2, h3, and h6 have 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15206 ; 2673970028
• MDR Report Key: 12630928
• Report Number: 2518422-2021-05238
• Device Sequence Number: 3421892
• Product Code: BZD
• UDI-Device Identifier: 00606959026568
• UDI-Public: 00606959026568
• 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,Followup
• Report Date (Section B): 10/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: CAX400H12
• Device Catalogue Number: CAX400H12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 07/12/2023; 08/13/2025
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 07/18/2023; 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown