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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CLEARSIGHT FINGER CUFF SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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EDWARDS LIFESCIENCES DR CLEARSIGHT FINGER CUFF SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number CSCL
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 02/23/2019
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation; it was discarded at the hospital. Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event. Lot number was not provided, therefore review of the manufacturing records could not be completed. 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 use on these above stated factors that can lead to inaccurate values. It is unknown if user or procedural factors played a role in the stated 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 the blood pressure (map in particular) obtained from the clearsight system was more than 40mmhg off the value of a femoral arterial line in a tavr case. Unknown what trouble shooting occurred, but the finger cuff was considered suspect. No patient complications were reported. Patient demographics were unable to be obtained.
 
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Brand NameCLEARSIGHT FINGER CUFF
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
EDWARDS LIFESCIENCES DR
parque industrial de itabo
carr. sanchez km 18.5
haina, san cristobal
DR
Manufacturer (Section G)
EDWARDS LIFESCIENCES DR
parque industrial de itabo
carr. sanchez km 18.5
haina, san cristobal
DR
Manufacturer Contact
lynn selawski
1 edwards way
irvine, CA 92614
9497564386
MDR Report Key8426346
MDR Text Key139170283
Report Number2015691-2019-00900
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,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCSCL
Device Catalogue NumberCSCL
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? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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