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

Model Number	CA761TS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Headache (1880); Sore Throat (2396); Unspecified Respiratory Problem (4464); Unspecified Eye / Vision Problem (4471)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
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.The manufacturer received information alleging soreness in eyes, headache, nasal/throat irritation.There was no report of serious or permanent harm or injury.No medical intervention was specified by the patient.The device was returned to the manufacturer's product investigation laboratory for investigation.The investigation concluded that the evidence of sound abatement foam degradation/breakdown was not observed in this device.The airflow was verified to be operating correctly.The secondary findings were the humidifier tank returned with water in the humidifier tank, dust in humidifier, pca and humidifier heater plate, contamination on humidifier bottom enclosure, humidifier seal, heater plate and on the enclosure that the heater plate sits on with excessive dust in sound abatement foam.The investigation was unable to address the complaint or symptoms.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: BIPAP AUTO BIFLEX
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 22004990
• Report Number: 2518422-2025-044744
• Device Sequence Number: 17919558
• Product Code: BZD
• UDI-Device Identifier: 00606959014206
• UDI-Public: (01)00606959014206
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 05/12/2025

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: CA761TS
• Device Catalogue Number: CA761TS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2014
• 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 Sex: Unknown