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

Model Number LTV 1200

Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913)

Patient Problem Burn(s) (1757)

Event Date 10/12/2017

Event Type  Injury  

Manufacturer Narrative

Vyaire has requested additional information to clarify if it was the patient or the respiratory therapist that was injured.Any additional information provided by the customer will be included in a follow up report.Results of investigation: a vyaire certified service technician was unable to verify the customer's reported issue.The device passed 99 hour extended test at the customer's settings without any unusual alarms and conditions.After 99 hour period of operation, the device operated within its specified ranges in temperature.The device failed the final test for slight non-conformities on calculated vti average.This slight non-conformity will not affect the way the device ventilates.The event trace contains no unusual alarm types of incident counts.All event trace entries are consistent with normal device operation.

Event Description

The customer reported that model lap top ventilator 1200 was hot to touch and burned a patient to the point where it caused blistering.Upon further investigation, the customer stated that it was most likely the respiratory therapist who was burned by the device, not the patient.Vyaire has requested additional clarification regarding the reported incident.

• Brand Name: LTV 1200 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL, INC; 17400 medina road; suite 100; plymouth MN 55447
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7014729
• MDR Text Key: 91509185
• Report Number: 2031702-2017-01989
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• 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: 18888-501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention