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

Model Number	DSX1130S11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Unspecified Kidney or Urinary Problem (4503)
Date of Event	05/14/2025
Type of Reportable Event	Death
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.This report was related to a dreamstation bipap avaps30 device.The manufacturer received information the patient experienced "infection, kidney failure and death".The device worked but the patient couldn't tolerate it on their face very long since it felt like it was smothering them.The patient had a bad infection.The patient went to the hospital and was given antibiotics, but their kidneys shut down.The patient then experienced kidney failure and passed away.The device was cleaned everyday using sterile water.Medical intervention was not specified.The manufacturer was made aware of this complaint through a representative of the customer.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: DREAMSTATION BIPAP AVAPS30
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 22878244
• Report Number: 2518422-2025-109323
• Device Sequence Number: 13355053
• Product Code: MNS
• UDI-Device Identifier: 00606959424449
• UDI-Public: (01)00606959424449
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K102465
• 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
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

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: DSX1130S11
• Device Catalogue Number: DSX1130S11
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female