MAUDE Adverse Event Report: WELCH ALLYN INC LIFE2000 VENTILATOR PACKAGED; 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	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Baxter is in the process of inspecting the life 2000 power cord.There was no allegation of patient or caregiver injury or death reported from this alleged incident.Investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
Event or Problem Description
Baxter received a report from a baxter technician stating the life 200 power cord had damage with exposed copper wires.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
Additional Manufacturer Narrative
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.Baxter has contacted the account three times requesting the device to be returned for inspection.The account was unresponsive to the attempts and the device did not return to manufacture.Therefore, baxter is completing this complaint due to the amount of time.Based on this information, no further action is required.Although there was no reported injury with this event, if the report of a damaged power cord with exposed copper wires were to recur, it could potentially cause serious injury or death.Therefore, baxter is reporting this event.
Event or Problem Description
Baxter received a report from a baxter technician stating the life200 power cord had damage with exposed copper wires.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: LIFE2000 VENTILATOR PACKAGED
• Common Device Name: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: daniela avila ; 4341 state street; skaneateles falls, NY 13153 ; 8129310130
• MDR Report Key: 20534624
• Report Number: 1316463-2024-00140
• Device Sequence Number: 12432729
• Product Code: NOU
• UDI-Device Identifier: 00887761978201
• UDI-Public: (01)00887761978201
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/26/2024
• 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
• Patient Sex: Unknown