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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL LTV 1200 VENTILATOR VENTILATOR, HIGH FREQUENCY

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VYAIRE MEDICAL LTV 1200 VENTILATOR VENTILATOR, HIGH FREQUENCY Back to Search Results
Model Number LTV 1200
Device Problem Mechanical Problem (1384)
Patient Problem Vascular Dissection (3160)
Event Date 04/14/2020
Event Type  Malfunction  
Manufacturer Narrative

Vyaire medical file identification: (b)(4). At this time, the suspect device has not been returned for evaluation. Therefore, root cause has not been determined yet. Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.

 
Event Description

The customer reported to vyaire medical that after replacing the turbine and flow valve of ltv 1200; the turbine has weird noise and the flow valve volume delivery is too high. At this time, there is no information regarding patient involvement associated with the reported event.

 
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Brand NameLTV 1200 VENTILATOR
Type of DeviceVENTILATOR, HIGH FREQUENCY
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa, il
Manufacturer (Section G)
VYAIRE MEDICAL INC.
17400 medina road suite 100
minneapolis, mn
Manufacturer Contact
mindy faber
26125 n. riverwoods blvd.
mettawa, il 
MDR Report Key10049999
MDR Text Key195746404
Report Number2031702-2020-03480
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK060647
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial
Report Date 04/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/12/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberLTV 1200
Device Catalogue Number18888-006
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/22/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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