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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES VOLUMEVIEW THERMODILUTION CABLE SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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EDWARDS LIFESCIENCES VOLUMEVIEW THERMODILUTION CABLE SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number EVVVTC1
Device Problem Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/11/2021
Event Type  malfunction  
Manufacturer Narrative
Ev1000 volumeview cable was returned and the evaluation process is ongoing. The device service history record review was completed, and all manufacturing inspections passed with no non-conformances. Results of product evaluation will be provided through a supplemental report.
 
Event Description
As reported, during use in patient of this ev1000 volumeview cable, the temperature value measured was lower than the one displayed on the patient monitor, which lead to failure to calculate the cardiac output normally. It is unknown what temperature they were comparing against. The cable was replaced for a new one and the issue was solved. Unfortunately, no further information was available. There was no allegation of patient injury. Patient demographics requested but not available.
 
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Brand NameVOLUMEVIEW THERMODILUTION CABLE
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer Contact
lynn thomas
1 edwards way
irvine, CA 92614
9497564386
MDR Report Key11782058
MDR Text Key251712060
Report Number2015691-2021-02822
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K203131
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2021
Device Model NumberEVVVTC1
Device Catalogue NumberEVVVTC1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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