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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)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/23/2019
Event Type  malfunction  
Manufacturer Narrative
The product will not be returned. The serial number is unknown. The disposition of the device is unknown. Without return of the product, it is not possible to determine if damages or defects existed on the product. No further actions will be taken at this time. The device history record review could not be completed as the serial number is unknown. These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise. These devices are typically used in intensive care units or operating rooms where patients are closely monitored. With any hemodynamic monitoring, pressure readings can change quickly and dramatically. 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 user on these above stated factors that can lead to inaccurate values. It is unknown whether any user or procedural factors contributed in this event. 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.
 
Event Description
It was reported that there were inaccurate clearsight map readings during patient monitoring. The readings were off by 10 ¿ 20 mmhg. It is unknown what the clearsight map readings were being referenced against. The issue was isolated to a new heart reference sensor device. The other clearsight components were not considered suspect. The patient demographic information and type of surgery performed are unknown. There was no patient harm or injury.
 
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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 thomas
one edwards way
irvine, CA 92614
9497564386
MDR Report Key8479870
MDR Text Key141041778
Report Number2015691-2019-01160
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
Report Date 01/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEVHRS
Device Catalogue NumberEVHRS
Was Device Available for Evaluation? No
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
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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