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

Model Number LTV 1150

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

Patient Problem Death (1802)

Event Date 06/01/2020

Event Type  Death  

Manufacturer Narrative

The equipment was received in vyaire facility and placed on extended testing/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

The customer reported that a patient passed away while on the ltv 1150 ventilator last (b)(6) 2019 and they want to send it in for evaluation.There are no allegations being made that the patient's death was caused by the unit.The patient has tracheostomy and the setting of the vent was simv, rr15 vt/0 ps18 peep +5 high pressure alarm 60 low pressure alarm 2.

Manufacturer Narrative

Result of investigation: the vyaire failure analysis laboratory received the suspect component and performed a failure investigation.Bench testing was performed and the vent passed extended tests at customer settings with no abnormalities.Flow performance and tidal volume failed for non conformance.These slight non-conformance would not result in a failure to ventilate properly.Review of the event trace revealed that the ventilator behaved as designed and the various alarm codes observed are considered normal operation.

• 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: 10299452
• MDR Text Key: 199629140
• Report Number: 2031702-2020-03576
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00845873002726
• UDI-Public: (01)00845873002726(11)20110716
• 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: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• 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: 07/01/2020
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death