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

Model Number LTV 1200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 02/14/2020

Event Type  malfunction  

Manufacturer Narrative

The ventilator was received in house at the carefusion facility in (b)(4).For evaluation.The unit was placed on tests and event trace is being reviewed.No root cause has been determined yet since investigation is still ongoing.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that a patient involved with ltv 1200 passed away mainly because of the patient's condition.It was also reported that during the time of death, the patient was not connected to the ventilator.

Manufacturer Narrative

Result of investigation: vyaire medical failure analysis laboratory investigation revealed that the suspect device function normally for the settings provided.Unit passed 108 hours extended tests at run-in settings.However, unit failed troubleshooting final test at pressure and oxygen blending performance.

• Brand Name: LTV 1200 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9826197
• MDR Text Key: 183236232
• Report Number: 2031702-2020-03424
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00845873000364
• UDI-Public: (01)00845873000364(11)20130710
• Combination Product (y/n): N
• PMA/PMN Number: K060647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTV 1200
• Device Catalogue Number: 18888-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1