MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000NI CLINICAL PLATFORM; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number EV1000NI

Device Problem Incorrect Measurement (1383)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The events occurred between (b)(6) 2017 and (b)(6) 2018.The serial numbers for the involved devices were not supplied; therefore, further review of the related manufacturing records could not be performed.No product was returned for evaluation.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.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 per article "the clearsight system for postoperative arterial blood pressure monitoring after carotid endarterectomy: a validation study" (leonie m.M.Fassaert et al.), the following complaints were identified: inaccurate values out of acceptable clinical range for systolic and diastolic bp when compared to invasive radial bp with overtreatment and undertreatment.The bias (precision) of bpcs compared to bprad was -10 (13.6), 8 (7.2) and 4 (7.8) mm hg for systolic, diastolic and mean arterial pressure (map), respectively.Based on bpcs, the overall percentage of undertreatment was 5.6% and of overtreatment 2.45%.No further information was available.Patient demographics unable to be obtained.

• Brand Name: EV1000NI CLINICAL PLATFORM
• 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 15690216
• MDR Text Key: 302571120
• Report Number: 2015691-2022-08882
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K203131
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EV1000NI
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other