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

Model Number	DS660HS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	04/11/2025
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.The manufacturer received information from the patient alleging water chamber was getting very hot.Additionally, the patient also alleged difficulty breathing, got sick, went to the emergency room, and stayed at the hospital for 4 days.The device has not yet been returned to the manufacturer for evaluation.Should further investigation provide new information that impacts the outcome of the investigation or the associated medical device reporting, a supplemental report will be submitted accordingly.

• 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: 24746444
• Report Number: 2518422-2026-010240
• Device Sequence Number: 8743649
• Product Code: BZD
• UDI-Device Identifier: 00606959005952
• UDI-Public: (01)00606959005952
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: DS660HS
• Device Catalogue Number: DS660HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2015
• 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: Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female