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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 LTV 1150
Device Problem No Apparent Adverse Event (3189)
Patient Problem Death (1802)
Event Date 03/05/2020
Event Type  Death  
Manufacturer Narrative
Vyaire complaint number: (b)(4).Any additional information provided by the customer will be included in a follow up report.At this time, vyaire has not received the suspect device/component for evaluation.
 
Event Description
It was reported to vyaire that a patient expired while connected to the lap top ventilator 1150.The customer confirmed that there are no allegations against the suspect device.Bill to: (b)(6).Ship to: (b)(6).(b)(6).
 
Manufacturer Narrative
Result of investigation: the suspect device has been returned to the manufacturer for evaluation.The event trace was reviewed, fa lab investigation revealed that various alarm codes was considered as a normal operation.The unit behaved as designed, the ventilator was sent in for download.Technician performed bench testing, all testing done with a good known test ac adapter and patient circuit connected.The unit passed 108 hours extended tests at customer settings with no abnormalities.The unit passed troubleshooting final test which includes many alarm and ventilation functions.
 
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Brand Name
LTV 1200 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa, il
MDR Report Key9863186
MDR Text Key184371573
Report Number2031702-2020-03439
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00845873002726
UDI-Public(01)00845873002726(11)20170127
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 03/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberLTV 1150
Device Catalogue Number18984-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2020
Initial Date Manufacturer Received 03/05/2020
Initial Date FDA Received03/20/2020
Supplement Dates Manufacturer Received10/22/2020
Supplement Dates FDA Received11/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
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