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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT EVHRS NON-INVASIVE HEART REFERENCE SENSOR

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EDWARDS LIFESCIENCES CLEARSIGHT EVHRS NON-INVASIVE HEART REFERENCE SENSOR Back to Search Results
Model Number EVHRS
Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Resultor Readings (1535); Malposition of Device (2616)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 09/11/2018
Event Type  Injury  
Manufacturer Narrative
The device has not been received for examination. When the evaluation findings are available a supplemental report will be submitted. The device service history record review has not been completed. When the results are available a supplemental report will be submitted. (b)(4).
 
Event Description
It was reported that during patient monitoring with clearsight technology that the heart reference sensor (hrs) device provided inaccurate blood pressure readings. This was because the hrs device fell from the patient off of the or table. The anesthesiologist noticed at the 30 minute intermittent nibp cycle that the hrs device was incorrectly positioned. The appropriate position of the hrs was to be at the patient¿s heart level. The blood pressure reading was 30mmg higher than expected at 130/90 for about 30 minutes. The hrs device was then correctly positioned. The patient¿s actual blood pressure was 100/70. Non-invasive blood pressure monitoring was being used with clearsight monitoring during surgery. The patient was undergoing a kidney transplant surgery. The patient treatment was altered as more fluid would have been given even though svv was low. They did not use vasopressors on the patient. There was no harm or injury to the patient. This event was not a result of a product malfunction.
 
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Brand NameCLEARSIGHT EVHRS
Type of DeviceNON-INVASIVE HEART REFERENCE SENSOR
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92714
Manufacturer (Section G)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer Contact
lynn selawski
one edwards way
irvine, CA 92614
9497564386
MDR Report Key7928259
MDR Text Key122451661
Report Number2015691-2018-04001
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/23/2018
Device Model NumberEVHRS
Device Catalogue NumberEVHRS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2018
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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