MAUDE Adverse Event Report: VYAIRE MEDICAL LTM II; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	ASSY, PACKAGING LTM II
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire complaint number: (b)(4).Any additional information provided by the customer will be included in a follow up report.At this time, vyaire has not received the suspected device.
Event or Problem Description
It was reported to vyaire that the ltm ii wires are burned.The customer confirmed that there was no patient involvement associated with the reported issue.
Additional Manufacturer Narrative
Results of investigation: a vyaire failure analysis lab technician was able to verify the customer's reported issue.Visual inspection revealed brunt wires.The technician replaced the pigtail and the reported issue was resolved.The device passed all testing and met all vyaire manufacturer specifications.

• Brand Name: LTM II
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8108386
• Report Number: 2031702-2018-03095
• Device Sequence Number: 19339630
• Product Code: CBK
• UDI-Device Identifier: 00845873000333
• UDI-Public: (01)00845873000333(11)20140724
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

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: ASSY, PACKAGING LTM II
• Device Catalogue Number: 17650-001-99
• Device Lot Number: 140110043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1