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 Codes	Loss of consciousness (2418); Low Oxygen Saturation (2477); Confusion/ Disorientation (2553); Lethargy (2560); Sleepiness/Drowsiness/Somnolence (4850)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
The patient experienced ¿lethargic and unresponsive¿ and spo2 was 70% while receiving oxygen therapy on the life2000.The day prior to the event the patient¿s familial caregiver noted the patient had ¿increased sleepiness and confusion¿.The following day, the patient was wearing the life2000 with 4 lpm oxygen bleed in through her home oxygen concentrator (brand/model unknown).The patient became lethargic and unresponsive and emergency medical services (ems) were called.Per the caregiver, the oxygen concentrator was working properly and no drop in the flow meter was noted.There was no alleged device malfunction of the life2000, and no audible or visual alerts were reported.Upon arrival of ems, the patient¿s spo2 was 70% and the patient was placed on supplemental oxygen via face mask and transported to the hospital.The patient was placed on bipap in the emergency room and arterial blood gas showed a co2 level of 112.The patient was hospitalized and treatment alternated between bipap and high flow o2.Six days later the patient was discharged from the hospital and the following day the patient was admitted into hospice care.The patient is currently using the life2000 and tolerating therapy well.The caregiver declined a trainer visit to assess the device settings.No further information was available at the time of this report.
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: 21256651
• Report Number: 2183816-2025-00004
• Device Sequence Number: 12772189
• Product Code: NOU
• UDI-Device Identifier: 00887761978201
• UDI-Public: (01)00887761978201
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,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: 12/30/2024
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 01/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED HOME OXYGEN CONCENTRATOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female