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

Model Number LTV 1150

Device Problem No Apparent Adverse Event (3189)

Patient Problem Death (1802)

Event Date 03/05/2020

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.At this time, vyaire has not received the suspect device/component for evaluation.

Event Description

It was reported to vyaire that a patient expired while connected to the lap top ventilator 1150.The customer confirmed that there are no allegations against the suspect device.Bill to: (b)(6).Ship to: (b)(6).(b)(6).

Manufacturer Narrative

Result of investigation: the suspect device has been returned to the manufacturer for evaluation.The event trace was reviewed, fa lab investigation revealed that various alarm codes was considered as a normal operation.The unit behaved as designed, the ventilator was sent in for download.Technician performed bench testing, all testing done with a good known test ac adapter and patient circuit connected.The unit passed 108 hours extended tests at customer settings with no abnormalities.The unit passed troubleshooting final test which includes many alarm and ventilation functions.

• 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: 9863186
• MDR Text Key: 184371573
• Report Number: 2031702-2020-03439
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00845873002726
• UDI-Public: (01)00845873002726(11)20170127
• Combination Product (y/n): N
• 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: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/22/2020
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 11/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death