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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. LTV 1200 ICU/PEDIATIRC; VENTILATOR, CONTINUOUS, FACILITY USE
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VYAIRE MEDICAL, INC. LTV 1200 ICU/PEDIATIRC; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 18888-001
Device Problems Device Displays Incorrect Message (2591); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2022
Event Type  malfunction  
Event Description
Rt was with this vented patient in ct.While in ct, the long-term ventilation (ltv) vent began alarming and said "disc sense" then stopped ventilating patient.The patient was taken off the vent and ambu bagged for a few minutes while another rt brought in a new vent.The patient remained stable throughout incident and was placed on new vent without any harm occurring to the patient.The malfunctioning ltv was taken out of service and sent to bio med this morning.The screen on ltv vent also does not work.
 
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Brand Name
LTV 1200 ICU/PEDIATIRC
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
VYAIRE MEDICAL, INC.
1100 bird center drive
palm springs CA 92262
MDR Report Key14159670
MDR Text Key289610989
Report Number14159670
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/13/2022,04/12/2022
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 Model Number18888-001
Device Catalogue Number18888-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/13/2022
Date Report to Manufacturer04/20/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/20/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age21900 DA
Patient SexMale
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