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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL LTV 1000 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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VYAIRE MEDICAL LTV 1000 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number LTV 1000
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Information (3190)
Date of Event 09/25/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).A third party service technician serviced the ventilator.However, the service record has not been submitted yet to vyaire medical.Once the service record is available, a follow-up report will be submitted.
 
Event or Problem Description
The customer reported that the ltv ventilitaor is turning on/off by itself due to a bad keypad and membrane.At this time patient involvement associated with the event is unknown.
 
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Brand Name
LTV 1000 VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa, il
MDR Report Key10411529
Report Number2031702-2020-03579
Device Sequence Number2890175
Product Code CBK
UDI-Device Identifier00845873000203
UDI-Public(01)00845873000203
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K101643
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/25/2019
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 NumberLTV 1000
Device Catalogue Number10130-99
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/25/2019
Initial Report FDA Received Date08/14/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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