MAUDE Adverse Event Report: WELCH ALLYN INC 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	01/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon troubleshooting it was determined the power cord needed to be replaced.Physical damage of a cord would be readily noticeable to the user.The user would notice any integrity issues with the surrounding insultation (outer covering) when plugging or unplugging the device into the electrical outlet.If found to be damaged, the power cord and device would be immediately removed from use.The power supply cords, by design, meet (iec 60601-1-6 usability standard), (iec 60245-1:2003, annex a, designation 53) or (iec 60227-1:1993, annex a, designation 53).Additionally, specific electrical safety standards apply to each product and subsequent applicable usability testing.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this device.A power cord replacement was shipped direct to patient to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
Baxter received a report from a customer stating the device had power cord 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: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18758227
• Report Number: 1316463-2024-00032
• Device Sequence Number: 3729408
• Product Code: CBK
• UDI-Device Identifier: 00887761978201
• UDI-Public: 00887761978201
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/22/2024

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 02/22/2024
• 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