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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES NEXFIN MODEL 2 SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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EDWARDS LIFESCIENCES NEXFIN MODEL 2 SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number A2SYS
Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Resultor Readings (1535); Patient Data Problem (3197)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/20/2020
Event Type  malfunction  
Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received. Upon the return of the product a supplemental report will be sent with the investigation results, as well as the device history record review. 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.
 
Event Description
As reported, there was a problem with this ccnexfin system. It was suspected to not be reliable. The heart rate and blood pressure measurement data seemed incorrect. The disposables were changed but the issue persisted. There was no allegation of patient injury reported. The device was available for evaluation.
 
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Brand NameNEXFIN MODEL 2
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
one edwards way
irvine CA 92614
Manufacturer Contact
jonathan diaz
one edwards way
irvine, CA 92614
9492503939
MDR Report Key10405652
MDR Text Key204164127
Report Number2015691-2020-13111
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K122381
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,Followup
Report Date 07/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/12/2012
Device Model NumberA2SYS
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 Manufactured12/12/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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