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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE

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CAREFUSION, INC LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number LTV 1150
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem Pneumonia (2011)
Event Date 09/30/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). Results of investigation: carefusion performed bench testing on the unit. All testing was performed using a good known test patient circuit as well as a good known ac adapter. The ventilator passed 77 hours of extended tests at the customer's settings. The ventilator also passed the ltv final test which includes many ventilation and alarm functions. The service technician was unable to reproduce the reported alarm during bench testing; however, a review of the event trace log revealed one "flush er" condition and multiple "xdcr flt" and "xdc flt1" ranging from the date of (b)(6) 2016.

 
Event Description

It was reported to carefusion that a child was being air-lifted to the hospital. The nurse reported that the ventilator had malfunctioned and had to be switched out. The nurse was unclear of the ventilator alarm codes that appeared on the monitoring screen. The customer believed the code might have been an "xdcr" alarm. The child is on the ventilator 24 hours a day 7 days a week and was admitted to the hospital for pneumonia. The clinical director for the facility that owns the ventilator stated that the customer sounded as if they were making allegations that the ventilator was the cause for the child being admitted into the hospital. The child was removed from the home from child protective services and this is a cps case.

 
Manufacturer Narrative

Additional information was received within a call data worksheet from the customer.

 
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Brand NameLTV 1200 VENTILATOR
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
CAREFUSION, INC
22745 savi ranch parkway
yorba linda CA 92887
Manufacturer (Section G)
CAREFUSION, INC
17400 medina road suite 100
plymouth MN 55447
Manufacturer Contact
jill rittorno
22745 savi ranch parkway
yorba linda, CA 92887
MDR Report Key6125944
MDR Text Key60842787
Report Number2031702-2016-01498
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK060647
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation RESPIRATORY THERAPIST
Type of Report Initial,Followup
Report Date 12/28/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/23/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberLTV 1150
Device Catalogue Number18984-001
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/11/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 11/23/2016 Patient Sequence Number: 1
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