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

Model Number	660P
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Asthma (1726); Pulmonary Emphysema (1832); Headache (1880); Dizziness (2194); Cancer (3262); Unspecified Respiratory Problem (4464); Skin Inflammation/ Irritation (4545); Upper Respiratory Tract Irritation (4872)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.This report was related to a bipap pro biflex device.Nose irritation, respiratory tract irritation, dizziness and or headache, asthma, lung disease, cancer, and lung emphysema.Medical intervention was not specified.The manufacturer was made aware of this complaint through a representative of the customer.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
During internal review, it was determined that a duplicate report was previously submitted for this event under (b)(4).That submission was entered in error and should not be considered a separate or additional event.The current report on (b)(4) 2518422-2025-046233 reflects the accurate and intended submission for this complaint.No new information or new incident occurred; this correction is to clarify and remove the unintended duplicate report.

• Brand Name: BIPAP PRO BIFLEX
• 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 ; 7247330200
• MDR Report Key: 23653455
• Report Number: 2518422-2025-112116
• Device Sequence Number: 18648725
• Product Code: BZD
• UDI-Device Identifier: 00606959031166
• UDI-Public: (01)00606959031166
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 660P
• Device Catalogue Number: 660P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/21/2026
• 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
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown