MAUDE Adverse Event Report: WELCH ALLYN INC LIFE2000; CONTINUOUS, VENTILATOR, HOME USE

Model Number	BT-80-0008
Medical Device Problem Code	Electrical Power Problem (2925)
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
The baxter engineering received the compressor without the power cord or power adapter.No evidence of burning or smoking was found on the power inlet on the back of the device.Device passed testing.The only defect found was that the rubber power inlet cover was severed, no damage was found to the power inlet itself.Physical damage of a cord would be readily noticeable to the user.The user would notice any integrity issues with the surrounding insulation (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.The customer received a replacement device 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 stating the power cord was burnt.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: LIFE2000
• Common Device Name: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 20527550
• Report Number: 1316463-2024-00138
• Device Sequence Number: 8078409
• Product Code: NOU
• UDI-Device Identifier: 00887761978072
• UDI-Public: (01)00887761978072
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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-80-0008
• 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: 09/30/2024
• Initial Report FDA Received Date: 10/24/2024
• 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