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

Model Number A1SYS

Device Problems Incorrect, Inadequate or Imprecise Result or 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.

• Brand Name: NEXFIN STANDARD DEVICE
• Type of Device: SYSTEM, 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 Key: 5449852
• MDR Text Key: 39198178
• Report Number: 2015691-2016-00500
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K122381
• Number of Events Reported: 1
• 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 Received: 02/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: A1SYS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown