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

Model Number	BT-20-0002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/14/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported from the patient¿s caregiver, the patient died in conjunction with the life2000.On an unreported date the patient was hospitalized for unknown cause.While in the intensive care unit, the patient died.The patient utilized the device ¿24 hours a day, seven days a week¿ according to the patient's caregiver.No desaturations, error codes or alarms were reported during the patient's use of the life2000.At the time of the patient¿s death, the patient was not connected to the life2000.The cause of death was not reported; nor was it reported if an autopsy was performed.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: a service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.The device was not received for evaluation; 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): HILL-ROM ST. PAUL; 1020 west county road f; st. paul MN 55126
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20929714
• Report Number: 2183816-2024-00001
• Device Sequence Number: 17284785
• Product Code: NOU
• UDI-Device Identifier: 00887761978201
• UDI-Public: (01)00887761978201
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: BT-20-0002
• Device Catalogue Number: BT-20-0002A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 05/29/2025
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 67 YR
• Patient Sex: Female