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

Model Number	CAX400T12C
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Dyspnea (1816); Headache (1880); Hemorrhage/Blood Loss/Bleeding (1888); Dizziness (2194); Sore Throat (2396); Cough (4457); Epistaxis (4458); Dry Mouth (4485)
Date of Event	01/28/2022
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 in the airway from device and black particles on the filter.Patient also alleged having trouble breathing, throat irritation, and a sore/bleeding throat.Patient also alleged that the device is noisy.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
The manufacturer previously reported information in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.Additional information was received that the patient is also alleging severe coughing, headache, bleeding mouth and nose, feeling lightheaded, and a dry throat while using the device.Patient also alleged the device has a burning odor.The date of the event/date of awareness has also been updated to 01/28/2022.Please see sections b3 and h6 for this updated and corrected information.The previous report was also filed as an initial/final, however the manufacturer's investigation is now ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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 visualization of particles in the airway from device and black particles on the filter.Patient also alleged having trouble breathing, throat irritation and sore/bleeding throat, severe coughing, headache, bleeding mouth and nose, feeling lightheaded and dry throat.Patient also alleged that the device is noisy and has burning odor.There was no report of patient harm or injury.The device was returned to the manufacturer's service center for further evaluation.The device was evaluated.There was no mention of visual finding to the external part of the device.The internal aspect of the device was inspected.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There were no errors found.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation and unit scrapped due to age.

• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13769401
• Report Number: 2518422-2022-10128
• Device Sequence Number: 12013942
• Product Code: BZD
• UDI-Device Identifier: 00606959034518
• UDI-Public: 00606959034518
• 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): N
• 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): 06/20/2023

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: CAX400T12C
• Device Catalogue Number: CAX400T12C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 01/28/2022; 05/02/2023
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 10/12/2022; 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2018
• 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