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

Model Number	AH660HS
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Asthma (1726); Headache (1880); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Vomiting (2144); Dizziness (2194); Respiratory Tract Infection (2420); Unspecified Respiratory Problem (4464); Eye Irritation (4803)
Date of Event	10/09/2023
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.The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged eye irritation, nose irritation, respiratory tract irritation, dizziness and/or headache, hypersensitivity and nausea / vomiting, asthma.Medical intervention was not specified.No additional information can be requested at this time.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.
Additional Manufacturer Narrative
Added device information on box d.
Additional Manufacturer Narrative
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 an issue related to a cpap device's sound abatement foam.The patient has alleged eye irritation, nose irritation, respiratory tract irritation, dizziness and/or headache, hypersensitivity and nausea / vomiting, asthma.Medical intervention was not specified.No additional information can be requested at this time.During the evaluation of the device at the third-party service center, the device was visually inspected and found no evidence of foam degradation during the evaluation, the device powered on and air flow was confirmed.The device's downloaded logs were reviewed by the third-party service center.There was two error code found.During evaluation there was secondary findings and dust was observed.The third-party service center concludes that they couldn't confirm the customer's allegation and there was no visible foam degradation and unit got corrected.Box h: evaluation method code, evaluation results code, component code grid and conclusion code grid has been updated.

• Brand Name: BIPAP PRO 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: 20733813
• Report Number: 2518422-2024-071077
• Device Sequence Number: 8922466
• Product Code: BZD
• UDI-Device Identifier: 00606959005921
• UDI-Public: (01)00606959005921
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: AH660HS
• Device Catalogue Number: AH660HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 12/11/2024; 03/03/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 12/11/2024; 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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