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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT PRESSURE CONTROLER KIT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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EDWARDS LIFESCIENCES CLEARSIGHT PRESSURE CONTROLER KIT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number PC2K
Device Problems Incorrect Measurement (1383); Calibration Problem (2890)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/08/2020
Event Type  malfunction  
Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received. Upon the return of the product a supplemental report will be sent with the investigation results, as well as the device history record review. 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 part of this monthly review.
 
Event Description
As reported, during use with a patient using this ev1000ni system, there was a 40-50 mmhg difference in the mean arterial pressure between the clearsight system and a nibp. There were no error messages displayed on the monitor. It was unknown if the problem was due to a calibration issue. There was no allegation of patient injury reported. The device was available for evaluation.
 
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Brand NameCLEARSIGHT PRESSURE CONTROLER KIT
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
one edwards way
irvine CA 92614
Manufacturer Contact
jonathan diaz
one edwards way
irvine, CA 92614
9492503939
MDR Report Key10226118
MDR Text Key198696833
Report Number2015691-2020-12405
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K140312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 06/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/20/2022
Device Model NumberPC2K
Device Catalogue NumberPC2K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2020
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 Manufactured03/20/2017
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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