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

Model Number	BT-20-0002
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the power cord needed to be replaced.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.A replacement was sent overnight to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
Baxter received a report from a baxter technician to report the l2k serviced ventilator power cord frayed and had copper wires exposed.The bed was located at the account.This occurred at home before use.There was no patient injury or death reported with this event.The reporter already communicated this event to another baxter department or authority: patient talked to clinical team to troubleshoot issue.
Additional Manufacturer Narrative
The baxter technician found the power cord needed to be replaced.A replacement was sent overnight to resolve the reported event.Based on this information, no further action is required.

• 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: 22485145
• Report Number: 2183816-2025-00042
• Device Sequence Number: 15463977
• Product Code: NOU
• UDI-Device Identifier: 00887761978201
• UDI-Public: (01)00887761978201
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K170037
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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
• Device Model Number: BT-20-0002
• Device Catalogue Number: BT-20-0002A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: N/A.
• Patient Sex: Unknown