• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

VYAIRE MEDICAL LTV 1200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8412335
MDR Text Key138529773
Report Number2031702-2019-03186
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00845873002726
UDI-Public(01)00845873002726(11)20080531
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060647
Number of Events Reported1
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 NumberLTV 1150
Device Catalogue Number18984-001
Device Lot NumberF21457
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/11/2019
Initial Date FDA Received03/12/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/31/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-