MAUDE Adverse Event Report: LIFE2000 VENTILATOR PACKAGED; VENTILATOR, CONTINUOUS, FACILITY 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	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report from a baxter technician stating the power cord had damage with exposed copper wires.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The baxter technician found the power cord needed to be replaced.The breathe technologies life2000® ventilation system is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.Specifically, the system is applicable for adult patients who require the following types of ventilatory support: positive pressure ventilation, delivered invasively (via et tube) or non-invasively (via mask).Assist/control mode of ventilation.The technician replaced the power cord to resolve the reported event.Based on this information, no further action is required.

• Brand Name: LIFE2000 VENTILATOR PACKAGED
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer Contact: estephania cardenas ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 19138303
• Report Number: 1316463-2024-00047
• Device Sequence Number: 21191631
• Product Code: CBK
• UDI-Device Identifier: 00887761978201
• UDI-Public: 00887761978201
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2024

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/18/2024
• 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
• Patient Sex: Unknown