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	Respiratory Tract Infection (2420)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a patient experienced respiratory infection while using a bipap pro biflex.The patient was diagnosed with copd, sinuses issues, sleep apnea and a chronic cough.The device settings during the event were reported to be unknown.During the event, the patient was stable.Clinical expert assessed and determined that the reported event makes no allegation of any specific device malfunction, use error, failure, labeling, or other deficiency that is relevant to the harms reported.Based on available information at this time, the alleged copd that resulted in the patient being hospitalized is assessed as not related to the device in this case.Also, thus far testing of the sound abatement foam has shown no evidence to suggest any potential exposure to foam vocs/particulates would result in any serious harm or death.The event is reportable due to recalled device with serious injury and non-serious injury.Believed that the device caused serious injury.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.

• 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: 24940062
• Report Number: 2518422-2026-011045
• Device Sequence Number: 21066785
• Product Code: BZD
• UDI-Device Identifier: 00606959005952
• UDI-Public: (01)00606959005952
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: 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: Not provided
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2015
• 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
• Patient Age: 74 YR
• Patient Sex: Male