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

Model Number	AH760HS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Headache (1880); Inflammation (1932); Dizziness (2194); Unspecified Kidney or Urinary Problem (4503)
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 that the patient alleging dizziness, headache, inflammatory response and kidney (disease/toxicity).There was no report of medical intervention.The manufacturer was made aware of this complaint through a representative of the customer.The device has not been returned to the manufacturer.At this time, no further investigation can be requested at this time.If any additional information is received, a supplemental 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: 20478640
• Report Number: 2518422-2024-63262
• Device Sequence Number: 8166372
• Product Code: BZD
• UDI-Device Identifier: 00606959005983
• UDI-Public: (01)00606959005983
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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: AH760HS
• Device Catalogue Number: AH760HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2015
• 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: Other
• Patient Sex: Unknown