MAUDE Adverse Event Report: VYAIRE MEDICAL INC. ASSY, PACKAGING LTM II; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	LTM II
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that the ltm kit input cable was burnt.The customer confirmed that there was no patient involvement associated with the reported event.This happened during testing.
Additional Manufacturer Narrative
Result of investigation: the vyaire failure analysis laboratory received the suspect component and performed a failure investigation and was able to confirm the reported issue.Visual inspection revealed a physically damaged pigtail that was burnt and melted with torn insulation exposing wires.Uut had overheated and melted due to excessive over current.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: ASSY, PACKAGING LTM II
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12054558
• Report Number: 2021710-2021-14091
• Device Sequence Number: 14555761
• Product Code: CBK
• UDI-Device Identifier: 00845873000333
• UDI-Public: (01)00845873000333(11)20140428
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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
• Operator of Device: Health Professional
• Device Model Number: LTM II
• Device Catalogue Number: 17650-001-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1