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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL LTV 1200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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VYAIRE MEDICAL LTV 1200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number LTV1150
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Information (3190)
Date of Event 08/07/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).A third party service technician evaluated the ventilator and was able to verify customer's reported problem.The technician replaced the power board to resolve the issue.
 
Event or Problem Description
The customer reported that the lap top ventilator 1150 alarmed reset.At this time, there is no information regarding patient involvement associated with the reported event.
 
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Brand Name
LTV 1200 VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa, il
MDR Report Key10497636
Report Number2031702-2020-03655
Device Sequence Number2160150
Product Code CBK
UDI-Device Identifier00845873002740
UDI-Public(01)00845873002740
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K101643
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/07/2020
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
Operator of Device Health Professional
Device Model NumberLTV1150
Device Catalogue Number18984-006-99
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/07/2020
Initial Report FDA Received Date09/04/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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