MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AVAPS30 AAM; (VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING)

Model Number	CAX1130S12
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
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 that the patient claims that the unit ventilator is inoperative and overheating, yet it will run, then stop, and then not run for a bit, related to a bipap device's sound abatement foam.No medical intervention was specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
In previous report legacy complaint id was missed to captured and updated in this report.
Additional Manufacturer Narrative
This ra was incorrectly reported and is not reportable.Any further reporting needed will be done in src tw (b)(4).

• Brand Name: DREAMSTATION BIPAP AVAPS30 AAM
• Common Device Name: (VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING)
• 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: 21262433
• Report Number: 2518422-2025-009140
• Device Sequence Number: 4336697
• Product Code: MNS
• UDI-Device Identifier: 00606959425507
• UDI-Public: (01)00606959425507
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K102465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2025

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: CAX1130S12
• Device Catalogue Number: CAX1130S12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 10/08/2024; 10/08/2024
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 01/29/2025; 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• 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-1973-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown