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 Adult Respiratory Distress Syndrome (1696)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Any additional information provided by the customer will be included in a follow up report.At this time, vyaire has received the suspect device/component for evaluation.When the results of investigation become available, a follow up report will be submitted.

Event Description

It was reported to vyaire that a patient experienced respiratory distress while connected to the lap top ventilator 1150.No further information was provided by the customer.

• Brand Name: LTV 1200 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 17400 medina road; suite 100; plymouth MN 55447
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8412335
• MDR Text Key: 138529773
• Report Number: 2031702-2019-03186
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00845873002726
• UDI-Public: (01)00845873002726(11)20080531
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: LTV 1150
• Device Catalogue Number: 18984-001
• Device Lot Number: F21457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2008
• 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