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

Model Number	ARX200S15
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Unspecified Gastrointestinal Problem (4491); Unspecified Hepatic or Biliary Problem (4493)
Date of Event	08/20/2021
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 liver and digestive disease.There is no report of the medical intervention that the patient has received at this time.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 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 an issue related to a cpap device's sound abatement foam.Patient was alleging to develop liver and digestive disease.This event is assessed as not related to the device in this case.Based on the available information, the manufacturer concludes no further action is necessary.No other medical intervention/treatment or additional information was reported.Since there is no customer information, the manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this a follow-up report will be filed.Section h6 updated in this report.
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 an issue related to a cpap device's sound abatement foam.Patient was alleged to develop liver and digestive disease.There is no report of the medical intervention that the patient has received at this time.The device was returned to the manufacturer's product investigation laboratory for investigation.During the investigation, observed an unknown dust contaminant on the flip doors, pca, top enclosure, rear panel, ui panel, bottom enclosure, inside iso port, blower, and blower box.Observed black hairlike contaminant on the flip doors, ui panel, and bottom enclosure.A keratin-like substance was observed on the blower box outlet.Evidence of sound abatement foam degradation/breakdown was not observed.The device's downloaded event log was reviewed by the manufacturer and found erorrs.The manufacturer confirmed no presence of degraded sound abatement foam.In this report, section d9, g3, h3, h6 has been updated.

• Brand Name: DREAMSTATION CPAP, AR
• 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: 12474952
• Report Number: 2518422-2021-04036
• Device Sequence Number: 3780282
• Product Code: BZD
• UDI-Device Identifier: 00606959047969
• UDI-Public: 00606959047969
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 02/19/2025

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: ARX200S15
• Device Catalogue Number: ARX200S15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 07/31/2023; 01/31/2025
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 07/31/2023; 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown