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

Model Number A1SYS

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be evaluated; however, at the time of this report, the device has not been returned.A supplemental report will be submitted to communicate the results of the complaint investigation results.

Event Description

It was reported that during use of ccnexfin monitor, the monitor would power on intermittently.The clinician believed that the patient values displayed were not accurate.The values appeared low.There were no fault or alert messages observed.As soon as the suspicion of inaccurate measurements became apparent, the customer stopped using the monitor.Therefore, the patient was not treated based on the perceived inaccurate values.No troubleshooting was performed.No patient compromise was reported.No other system-related devices were reported as suspect.No patient demographics were able to be obtained.

Manufacturer Narrative

The review of the device history record supports that there were no non-conformances noted for any reason and met all specifications upon distribution.The device was expected to be returned for evaluation; however, new information was received that the device is not available for evaluation.

• 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 ; 9497564386
• MDR Report Key: 6473595
• MDR Text Key: 72345894
• Report Number: 2015691-2017-00946
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K122381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Model Number: A1SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1