MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIFE2000; CONTINUOUS, VENTILATOR, HOME USE

Model Number	BT-20-0002
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/25/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported a patient allegedly passed away while using a life2000 ventilator.Reportedly while hospitalized the device ¿either stopped running or ran only intermittently¿ while the patient was connected to the device.It was reported the patient was connected to the device at the time of passing.Per the death certificate the cause of death listed was listed as ¿acute-on-chronic respiratory failure¿ and ¿anoxic brain injury due to pre-hospital cardiac arrest.¿ baxter¿s investigation is ongoing into the sequence of events from the patient¿s initiation of life 2000 therapy to the patient¿s death, including any servicing/maintenance performed on the associated life 2000 device.No further information was available at the time of this report.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: h6 and h11.H11: the device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: LIFE2000
• Common Device Name: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): WELCH ALLYN PRODUCTS, SKANEATELES; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23647138
• Report Number: 1316463-2025-01002
• Device Sequence Number: 4903431
• Product Code: NOU
• UDI-Device Identifier: 00887761978201
• UDI-Public: (01)00887761978201
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: BT-20-0002
• Device Catalogue Number: BT-20-0002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/02/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 56 YR
• Patient Sex: Male