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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000 CLINICAL PLATFORM WITH CLEARSIGHT FINGER CUFF OR CLEARSIGHT SYSTEM SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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EDWARDS LIFESCIENCES EV1000 CLINICAL PLATFORM WITH CLEARSIGHT FINGER CUFF OR CLEARSIGHT SYSTEM SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number EV1000NI
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/14/2017
Event Type  malfunction  
Manufacturer Narrative
Review of the manufacturing records support that there were no non-conformances noted during the manufacturing of the ev1000 ni platform and all specifications were met prior to release. A review of the service history supports that there have been no issues requiring servicing prior to this report. Examination of the returned platform was unable to confirm the reported events. Functional testing per procedure was executed with a golden (known ¿good¿) heart reference sensor (hrs) and the device passed all analysis with no issues noted for any reason. It was noted that the hrs that was sent with the system had already expired (2017-03-01). It is unknown whether the expired hrs, procedural processes or a specific circumstance played a role in the events, as the fault could not be replicated and no other issues were detected; the device performed as expected. With any hemodynamic monitoring, pressure readings can change quickly and dramatically. Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make such decisions. In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise. Pressure readings should correlate with the patient¿s clinical manifestations. Issues such as poor finger perfusion, improperly applied finger cuff, incorrectly sized finger cuff, improper application of the hrs or failing to zero the hrs sensor may lead to inaccurate hemodynamic measurements. The operators manual instructs the use on these above stated factors that can lead to inaccurate values. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
 
Manufacturer Narrative
The device is expected to be returned and evaluated. However, at the time of this report, it had not yet been received. A supplemental report will be sent upon receipt and examination of the suspect device. The results of the device history record review will also be communicated in our supplemental follow-up report.
 
Event Description
During a sales representative demonstration, the clearsight non-invasive platform displayed suspect blood pressure values. The device was tested on four separate patients using different cuffs; however, the issue persisted. There was a difference of approximately 25mmhg in the arterial blood pressure between the clearsight and the arm cuff and between the clearsight and the arterial line (arterial line and arm cuff were similar). No error message was displayed. No patient was treated based on the suspect values and there was no report of patient compromise resulting from this event.
 
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Brand NameEV1000 CLINICAL PLATFORM WITH CLEARSIGHT FINGER CUFF OR CLEARSIGHT SYSTEM
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
lynn selawski
1 edwards way
irvine, CA 92614
9497564386
MDR Report Key7106378
MDR Text Key254425522
Report Number2015691-2017-04219
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K160552
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2020
Device Model NumberEV1000NI
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2015
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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