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

Model Number	CAX400T12C
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Dyspnea (1816); Headache (1880); Nausea (1970); Dizziness (2194); Cough (4457); Unspecified Respiratory Problem (4464); Unspecified Eye / Vision Problem (4471); Skin Inflammation/ Irritation (4545)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
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 that the device caused sinus pressure/inflammation, eye puffiness, skin redness and irritation, dry cough, headaches, nausea, lightheaded and shortness of breath.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged that the device caused sinus pressure/inflammation, eye puffiness, skin redness and irritation, dry cough, headaches, nausea, lightheaded and shortness of breath.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacturer visually inspected the external part of the device and found minimal signs of dust/dirt contamination on top and bottom enclosures, ui panel, rear panel, sd cover flip door, accessory module flip door, control dial, keypad, blower box upper cap, blower, blower box, blower outlet seal, rear panel o-ring, p4 power connector.Pil technician observed no odor coming from the device.Pil technician observed an unknown contaminate inside the top and bottom enclosures, inside the ui and rear panels.The manufacturer visually inspected the device internally and found minimal dust contamination in the blower assembly.The humidifier showed a small amount of liquid ingress was observed on the blower and blower box.A contaminate consistent with keratin was observed on the blower box.Er-2243857 v01 addresses the issue of keratin.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 there was no evidence of sound abatement foam degradation, but a small amount of liquid ingress and dust contamination were observed and are consistent with being from an external source.

• 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: 13556031
• Report Number: 2518422-2022-04874
• Device Sequence Number: 4299586
• 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
• Report Date (Section B): 11/21/2023

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: 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: 01/19/2022
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2017
• 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