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

Model Number	CAX400H12
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Sore Throat (2396); Respiratory Tract Infection (2420)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged visualization of particles coming from the device.Patient also alleged sinus inflammation and nasal/throat irritation or soreness.There is no allegation of serious or permanent 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 april 09, 2024 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 alleged particles coming from the device, sinus inflammation and nasal/throat irritation or soreness.There was no report of patient harm or injury.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The device was evaluated by the manufacturer and using a known good power supply and power cord, they were able to confirm the device powered on and provided airflow.The manufacturer inspected the device, observed dust-like and fibrous and other unknown contamination was observed on and around the iso port, slight dust like contamination in the bottom enclosure, potential mineral deposits or dried liquid spots on the bottom of the blower motor and on the bottom of the blower box, indicating potential water ingress, observed multiple unknown contaminants in the bottom of the blower box and at the blower box seal location, that is inconsistent with degraded sound abatement foam.Dust-like and fibrous contamination was observed on the blower outlet seal.Evidence of sound abatement foam degradation/ breakdown was not observed.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 zero error codes.The manufacturer concludes that they were not able to confirm the customer complaint or directly address the patient's symptoms.There was no evidence of sound abatement foam degradation.Sections d8, d9, h2, h3, h6 has been updated in this report.

• Brand Name: DREAMSTATION CPAP PRO
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; respironics, inc.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; respironics, inc.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: rosko melissa ; philips respironics; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 13719926
• Report Number: 2518422-2022-09381
• Device Sequence Number: 5883110
• 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
• Report Date (Section B): 08/27/2024

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: 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: 03/01/2022
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2018
• 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