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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES DR FINGER CUFF SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number CSCL
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Low Test Results (2458)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/29/2019
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. No corrective actions will be taken at this time. A review of the manufacturing records indicated that the product met specifications upon release. 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. There is an expected difference in values between invasive and non-invasive technologies, but in this instance the difference in values were greater than 10%, therefore it is assumed that the clearsight finger cuff is incorrect. 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. In this event, no patient compromise was reported. 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. Other possible lot number- 61876712, mfg date 01/10/2019, exp date 01/09/2022.
 
Event Description
It was reported that during use, the clearsight finger cuff provided arterial blood pressure values of 72/48 mmhg (map: 57 mmhg), that were lower compared to an arterial sensor and to an arm cuff. The arterial blood pressure values provided by the arterial sensor were 96/55 mmhg (map: 69 mmhg). The ones provided by the arm cuff were 104/55 mmhg (map: 80 mmhg). The measurements with the clearsight and the arterial sensor were made in the same arm and the arm cuff was used on the other arm. No error message was displayed and there was no allegation of patient injury. The device was not available for evaluation since it was discarded by hospital. Patient demographics were unable to be obtained.
 
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Brand NameFINGER 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
samantha eveleigh
1 edwards way
irvine, CA 92614
9492503939
MDR Report Key9506602
MDR Text Key188682336
Report Number2015691-2019-04825
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeBE
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
Report Date 12/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/11/2020
Device Model NumberCSCL
Device Catalogue NumberCSCL
Device Lot Number61058969
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
Date Device Manufactured09/12/2017
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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