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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL LTV 2200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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VYAIRE MEDICAL LTV 2200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number LTV 2200
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2020
Event Type  malfunction  
Manufacturer Narrative
The suspect device was returned and evaluation is anticipated, but not yet begun.Once a final investigation is complete, a follow-up report will be submitted.
 
Event Description
The customer reported that the laptop ventilator 1200 experienced not delivering set volumes when on a patient.The customer stated he did not have vent settings but confirmed there was no patient harm associated with the reported event.
 
Manufacturer Narrative
Device evaluation: result of investigation: vyaire service technician was not able to verify customer's reported problem.All test performed and passed.The root cause was not determined.
 
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Brand Name
LTV 2200 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa IL 60045
MDR Report Key11024387
MDR Text Key222021682
Report Number2021710-2020-13015
Device Sequence Number1
Product Code CBK
UDI-Device Identifier10846446000313
UDI-Public(01)10846446000313(11)20090313
Combination Product (y/n)N
PMA/PMN Number
K060647
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLTV 2200
Device Catalogue Number17210-00
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
Initial Date Manufacturer Received 11/19/2020
Initial Date FDA Received12/16/2020
Supplement Dates Manufacturer Received01/07/2021
Supplement Dates FDA Received01/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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