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

Model Number	CAX501H12C
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Dyspnea (1816); Cough (4457)
Date of Event	01/26/2022
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 black particles in filter, shortness of breath and cough.There was no report of patient 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 was previously 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 received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged visualization of black particles in filter, shortness of breath and cough.There was no report of serious or permanent patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal visual inspection of the device was completed by the manufacturer.The manufacturer found evidence of dust contaminant inside the blower box at the location of the filter, on the pca, on the blower box, top enclosure, front panel, rear panel, bottom enclosure, the o-ring of the rear panel, on the blower cap, the blower, blower isolators, and the blower seal.The manufacturer also found evidence of keratin-like substance on the blower box outlet, blower seal, and contaminant on the blower seal.The manufacturer found no evidence of sound abatement foam degradation/breakdown.The manufacturer powered up the device and confirmed airflow.The device's downloaded event log was reviewed by the manufacturer and found no error logged.The manufacturer concludes there was evidence of multiple contaminations from the device.The manufacturer confirmed there was no evidence of sound abatement foam degradation/breakdown.Section d9, g3 and h6 has been updated/corrected in this report.

• Brand Name: DREAMSTATION EXPERT
• 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: 13568388
• Report Number: 2518422-2022-04866
• Device Sequence Number: 20349146
• Product Code: BZD
• UDI-Device Identifier: 00606959053175
• UDI-Public: 00606959053175
• 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): 03/15/2023

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: CAX501H12C
• Device Catalogue Number: CAX501H12C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2018
• 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