MAUDE Adverse Event Report: VYAIRE MEDICAL LTV 1200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number LTV 1150

Device Problem Mechanical Problem (1384)

Patient Problem Death (1802)

Event Date 05/10/2019

Event Type  Death  

Manufacturer Narrative

Vyaire complaint number: (b)(4).Any additional information provided by the customer will be included in a follow up report.Results of investigation: a vyaire failure analysis lab technician was unable to verify the reported issue.The device passed 262 hours of extended bench testing at the customer's settings.The device failed final test for battery operation.The slight non-conformance would not result in a failure to ventilate properly.

Event Description

It was reported to vyaire that the lap top ventilator 1150 failed while connect to a patient.The patient died a couple of days later in the hospital.The mother of the child noted that the doctor told her he had a brain aneurysm.

• Brand Name: LTV 1200 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 17400 medina road suite 100; minneapolis MN 55447
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 10581909
• MDR Text Key: 208391524
• Report Number: 2031702-2020-03692
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00845873002726
• UDI-Public: (01)00845873002726(11)20140208
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K060647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LTV 1150
• Device Catalogue Number: 18984-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 10 YR