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

Model Number LTV 1150

Device Problem Mechanical Problem (1384)

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

Event Date 01/28/2021

Event Type  Death  

Manufacturer Narrative

81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.However, the customer sent the event trace for review.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 to vyaire medical that a patient passed away while connected to the lap top ventilator 1150.At this time, no information is available regarding whether or not the device had anything to do with the patient's passing.

Manufacturer Narrative

Result of investigation: analysis of the event trace was performed.No physical analysis of the vent was done.The event trace show a continuous self reset due to a loss of an external power source causing the vent to continuously attempt to power on the vent.The issues found within the event trace indicated an unstable power source or lack thereof.

• 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: 11396636
• MDR Text Key: 234200221
• Report Number: 2021710-2021-13442
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00845873002726
• UDI-Public: (01)00845873002726(11)20140505
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• 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?: Yes
• Date Manufacturer Received: 08/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death