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

Model Number LTV 1150 VENTILATOR

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

Patient Problems Cardiac Arrest (1762); Neurological Deficit/Dysfunction (1982); Low Oxygen Saturation (2477)

Event Date 03/05/2016

Event Type  Injury  

Manufacturer Narrative

Any additional information provided by the customer will be included in a follow up report.(b)(4).Results of investigation: service technician performed bench testing.All testing performed using a known good test patient circuit as well as a known good ac adapter.Ventilator passed 90 hour extended tests at customer¿s settings.Ventilator failed ltv final test for non-conformities the flow performance test and with calculated tidal volume average.These slight non-conformities would not result in a failure to ventilate properly.

Event Description

The customer reported the patient became disconnected from model lap top ventilator 1150.The patient was low of oxygen and went into cardiac arrest.He was disconnected for approximately 10 minutes before being provided positive pressure ventilation via bag valve mask.Once stabilized, he was reported to have no brain activity.There is no reference to an equipment malfunction, the customer reported the event and requested an evaluation of the device.This was the customer's primary ventilator and was the device in use at the time of the event.

• Brand Name: LTV 1200 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 17400 medina road suite 100; plymouth MN 55447
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5549245
• MDR Text Key: 41939554
• Report Number: 2031702-2016-00541
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LTV 1150 VENTILATOR
• Device Catalogue Number: 18984-001-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2008
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 2 YR