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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 CSCU
Device Problems Display or Visual Feedback Problem (1184); 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 01/16/2019
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 during surgery, inaccurate values were displayed on an ev1000 monitor. The doctor administered two doses of ephedrine to the patient as the systolic arterial pressure was low. There was no sign of hemodynamic instability but the systolic arterial pressure value did not improve. In order to get another measure of the arterial pressure, the anesthesiologist connected a brachial cuff to the patient and the results displayed were: ev1000 ni: 76/57 mmhg and brachial cuff: 106/58 mmhg. After the procedure, the monitor was compared against other brachial cuffs and the issue was confirmed. An error message was not observed. The customer asserts that the malfunction was not with the monitor but attributed this event to the finger cuff. There was no allegation of patient injury. The finger cuff was not available for evaluation since it was discarded by the customer. 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 Key8337638
MDR Text Key136601205
Report Number2015691-2019-00483
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCSCU
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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