MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP PRO BIFLEX W/HTHUM SYSONE60SRS DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	DS660TS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Asthma (1726); Pulmonary Emphysema (1832); Headache (1880); Dizziness (2194); Cancer (3262); Insufficient Information (4580); Upper Respiratory Tract Irritation (4872)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was notified about a voluntary field safety notice/recall related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.There are no allegations of patient harm or serious injury mentioned in the complaint.No specific medical intervention was mentioned.The manufacturer was made aware of this information through the customer¿s legal representative.Due to potential legal issues surrounding this case, no further investigation or follow-up can be conducted.If any additional information is received, a follow-up report will be submitted.

• Brand Name: BIPAP PRO BIFLEX W/HTHUM SYSONE60SRS DOM
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): Respironics, Inc.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; +1(724)733-0200
• MDR Report Key: 21586394
• Report Number: 2518422-2025-102939
• Device Sequence Number: 18359798
• Product Code: BZD
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: 505
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/23/2026

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: Other
• Device Model Number: DS660TS
• Device Catalogue Number: DS660TS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 02/23/2024; 02/23/2024; 02/23/2024; 02/23/2024
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 09/10/2026; 09/15/2026; 09/17/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2013
• 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: N
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1974-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown