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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 Problem Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/22/2016
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for analysis; however, it has not been received yet. Upon return of the product for evaluation a supplemental report will be submitted with the evaluation findings.
 
Event Description
It was reported that during colorectal surgery, while monitoring a patient with the clearsight system; pump unit, pressure controller, heart reference sensor and ev1000ni system, there was a discrepancy in the systolic blood pressure reading. The reading measured 20-30 points different from the blood pressure cuff. There was also a discrepancy in the map values. The clearsight system components were removed from the patient when the discrepancy in values was observed. No troubleshooting was done to isolate a suspect component. The patient demographics are unknown. There was no treatment administered to the patient in conjunction with the inaccurate values. There was no harm or injury to the patient.
 
Manufacturer Narrative
One ev100ni heart reference sensor was received for product evaluation. The hrs unit was connected to a known good working clearsight system for testing. There was a fault message of ¿hrs out of range¿ error that displayed when trying to perform zeroing. When the hrs unit was flexed near the hdmi connector, thus bending the internal flat flex cable, this prevented the error message from occurring. An x-ray was taken of the suspect hrs unit and there was no damage noted. A visual inspection was completed and there was no physical damage found. There was no oil leakage found. The calibration test was performed and it passed the test. When bending near the hdmi connector causes a change in the error message display, it can be determined that there is an intermittent connection at the hdmi connector where the most stress from flexing can occur. This is a known issue with the hrs unit and corrective action has been generated to further investigate. The root cause is repetitive movement or flexing during use. The corrective action will allow for more bending and twisting cycles without discontinuity failures. In addition, the ifu states that the usable life is 90 days and exceeding the limit can eventually result in failures. The manufacturing date is april 2016; the unit was in use for seven months. The device service history record review was completed and all manufacturing inspections passed with no non-conformances. The reported event was confirmed by evaluation. Please refer to 2015691-2016-03602 for the ev1000ni pump unit; 2015691-2016-03603 for the ev1000ni pressure controller unit; 2015691-2016-03605 for the ev1000a platform system associated with this occurrence.
 
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Brand NameCLEARSIGHT EVHRS
Type of DeviceNON-INVASIVE HEART REFERENCE SENSOR
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer Contact
lynn selawski
one edwards way
irvine, CA 92614
9497564386
MDR Report Key6154245
MDR Text Key61723815
Report Number2015691-2016-03604
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
Type of Report Initial,Followup
Report Date 11/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/24/2018
Device Model NumberEVHRS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/24/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/08/2016 Patient Sequence Number: 1
Treatment
EV1000A, PUMP UNIT, PRESSURE CONTROLLER, BP CUFF
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