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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES NEXFIN STANDARD DEVICE SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number A1SYS
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Device Operates Differently Than Expected (2913)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2016
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned and evaluated; however, at the time of this report, evaluation results are not available. A supplemental report will be submitted to communicate the results of the complaint investigation results.
 
Event Description
It was reported that during use of the cc nexfin standard system, the customer suspected that the displayed values were 'too low' when measuring blood pressure. There was no report of patient compromise and no other devices were identified as suspect.
 
Manufacturer Narrative
The monitor was manufactured december 21, 2007 and review of the device history record supports that there were no non-conformances noted during the manufacturing of the referenced monitor. Additionally, no prior service has been documented for this device. Per edwards¿ procedures the useful life of the monitor is 5 years. The referenced monitor has significantly exceeded its useful life. The actual values, reported as ¿low,¿ were requested; however, the information was unable to be ascertained. Examination of the returned device confirmed a faulty heart rate sensor; noting ¿air in hose. ¿ additionally, physical damage was detected on the front of the monitor and the ic net entry and switch required replacement. The root cause of the issue was unable to be associated with any manufacturing defect. The front monitor and ic net entry were replaced. Unit testing was executed and calibration was performed for the monitor, wrist unit, ecg box and finger cuff. All functional testing, as well as electrical safety testing, was successfully performed without any issues noted for any reason. Edwards will continue to review and monitor all events. If action is required, an appropriate investigation will be performed.
 
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Brand NameNEXFIN STANDARD DEVICE
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
lynn selawski
1 edwards way
irvine, CA 92614
9492504386
MDR Report Key5449852
MDR Text Key39198178
Report Number2015691-2016-00500
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K122381
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 01/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA1SYS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/29/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/21/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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