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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 LTV2200
Device Problem Mechanical Problem (1384)
Patient Problem Apnea (1720)
Event Date 11/03/2020
Event Type  Injury  
Manufacturer Narrative
Any additional information received from the customer will be included in a follow-up report at this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determined yet.
 
Event Description
The customer reported to vyaire medical that the lap top ventilator 2200 ventilator was restarted continuously after being used for more than 1 day on the patient.The patient was removed from the ventilator and it caused failure of breathing.
 
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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
Manufacturer (Section G)
VYAIRE MEDICAL INC.
1100 bird center drive
palm springs CA 92262
Manufacturer Contact
peter sparacio
26125 n. riverwoods blvd.
mettawa, IL 60045
8333273284
MDR Report Key10922831
MDR Text Key218900651
Report Number2021710-2020-12929
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeID
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLTV2200
Device Catalogue Number22690-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/03/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/03/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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