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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 Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2017
Event Type  malfunction  
Manufacturer Narrative
One large size clearsight finger cuff was received for product evaluation. The reported issue regarding inaccurate blood pressure values obtained with the finger cuff was not confirmed. No visible damage was noticed from the returned unit. The pressure cuff inflated without any leakage during a leak test before decontamination. Information such as serial number, lot number, size, manufacture date of the unit were available during eeprom verification. Electrical testing also showed that all elements such as shield, led, and photodiode of returned unit all worked successfully. Although the cause of the complaint could not be determined, there was no indication of a manufacturing defect noted during the analysis. No actions will be taken at this time. 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, or incorrectly sized finger cuff may lead to inaccurate hemodynamic measurements. The operators manual instructs the user on these above stated factors that can lead to inaccurate values. It is unknown if user or procedural factors may have contributed to the reported 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 part of this monthly review.
 
Manufacturer Narrative
The device evaluation is anticipated. However the complaint could not be confirmed without the completion of the product evaluation. A supplemental report will be forthcoming with the evaluation results when received. A review of the manufacturing records indicated that the product met specifications upon release. Udi # (b)(4).
 
Event Description
It was reported that there was a difference in blood pressure when the clearsight finger cuff measured around 90mmhg while nibp (manchette) measured around 130mmhg. This was observed when the finger cuff was tried on a patient with atrial fibrillation. There were no patient complications reported. Patient demographic information requested but unavailable.
 
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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
brian hurd-servin
1 edwards way
irvine, CA 92614
9492506423
MDR Report Key6702549
MDR Text Key194834328
Report Number2015691-2017-02001
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/11/2018
Device Model NumberCSCL
Device Catalogue NumberCSCL
Device Lot Number60645597
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2016
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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