MAUDE Adverse Event Report: VYAIRE MEDICAL LTV 1150 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number LTV 1150

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/12/2021

Event Type  Death  

Manufacturer Narrative

The equipment was received in vyaire facility for evaluation.The unit is placed on extended test/run-in.No root cause has been determined at this time, since the 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

It was reported to vyaire that a patient passed away while connected to the lap top ventilator 1150 and requested to check the event trace.At this time, no information is available regarding whether or not the device had anything to do with the patient's passing.

Manufacturer Narrative

Device evaluation: the vyaire failure analysis laboratory received the suspect component and performed a failure investigation.The service technician was able to verify the reported problem "missing multiple screws".Visual inspection reveals three missing screws on the upper protective boot.The unit passed extended tests at run-in settings.The tidal volume & flow performance failed for non-conformance with measured bias flow.The measured bias flow was 11.10 while the expected is 11.00.V-home was performed.The rear weldment was replaced and all screws were installed at ltv (lap top ventilator) completion.The unit passed all testing.

• Brand Name: LTV 1150 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11554874
• MDR Text Key: 241789453
• Report Number: 2021710-2021-13572
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00845873002726
• UDI-Public: (01)00845873002726(11)20151231
• Combination Product (y/n): N
• PMA/PMN Number: K060647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LTV 1150
• Device Catalogue Number: 18984-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death