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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); Output Problem (3005)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 09/27/2019
Event Type  malfunction  
Manufacturer Narrative
The device evaluation is anticipated. However, the complaint cannot not be confirmed without the completion of a product evaluation. A supplemental report will be forthcoming with the evaluation and device history results when received.
 
Event Description
It was reported that during use, the clearsight finger cuff did not give the same values of systolic, diastolic and mean arterial pressure as the arm cuff or the arterial line. The comparison between the values of the finger cuff and the ones provided by the two other sources were not provided as they were changing according to the procedure. The measurements were not made in the same arm. No error message was displayed. The patient was not treated according to the wrong values. There was no allegation of patient injury reported. Patient demographic 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 Key9194626
MDR Text Key195043836
Report Number2015691-2019-03800
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,Followup
Report Date 09/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2019
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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