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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 06/23/2017
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. It is not known if some procedural factors may 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. 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. 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 use on these above stated factors that can lead to inaccurate values. Udi number- (b)(4).
 
Event Description
It was reported that there was a difference in blood pressure when the clearsight finger cuff measured around 80 to 90mmhg while nibp (manchette) measured around 150mmhg. In addition, there was a difference in the pulse rate when a nihon kohden pulse oximeter measured around 100bpm while around 80bpm was shown from the finger cuff. This was observed when the finger cuff was used during rehabilitation after the off pump bypass surgery to a patient with atrial fibrillation. There was no error messages observed. There were no patient complications reported. The device was discarded by the hospital therefore it is not available for evaluation. 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 Key6703245
MDR Text Key79969276
Report Number2015691-2017-02004
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
Report Date 06/23/2017
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? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/23/2017
Was Device Evaluated by Manufacturer? No
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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