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 Codes	Dyspnea (1816); Unspecified Respiratory Problem (4464)
Date of Event	09/07/2021
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 large amounts of phlegm.The patient was prescribed antibiotics in response to the reported event.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 jul 05, 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 patient to develop large amounts of phlegm.The patient was prescribed antibiotics in response to the reported event and patient also alleged difficulty in breathing/short of breath that are related cpap device's sound abatement foam.The device was returned to the manufacturer's product investigation laboratory for investigation.The manufacturer observed secondary finding and the dust/dirt contamination found at the iso port, on the motor casing/impellers, bottom panel, back panel, 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.Mineral spots consistent with water ingress were found within the blower box and on the motor casing.Slight black contamination at the blower seal of the blower box appears consistent with the keratin contamination.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 there is evidence of water ingress into the blower box.The manufacturer was unable to address the patient's symptoms.

• 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: 13076666
• Report Number: 2518422-2021-08611
• Device Sequence Number: 20289622
• 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): 08/26/2024

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: 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: 09/07/2021
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2017
• 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