MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR FINGER CUFF; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number CSCL

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However the complaint could not be confirmed without the completion of the product evaluation.A supplemental report will be forthcoming with the evaluation results when received.A review of the manufacturing records indicated that the product met specifications upon release.Udi # (b)(4).

Event Description

It was reported that there was a difference in blood pressure when the clearsight finger cuff measured around 90mmhg while nibp (manchette) measured around 130mmhg.This was observed when the finger cuff was tried on a patient with atrial fibrillation.There were no patient complications reported.Patient demographic information requested but unavailable.

Manufacturer Narrative

One large size clearsight finger cuff was received for product evaluation.The reported issue regarding inaccurate blood pressure values obtained with the finger cuff was not confirmed.No visible damage was noticed from the returned unit.The pressure cuff inflated without any leakage during a leak test before decontamination.Information such as serial number, lot number, size, manufacture date of the unit were available during eeprom verification.Electrical testing also showed that all elements such as shield, led, and photodiode of returned unit all worked successfully.Although the cause of the complaint could not be determined, there was no indication of a manufacturing defect noted during the analysis.No actions will be taken at this time.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.Issues such as poor finger perfusion, improperly applied finger cuff, or incorrectly sized finger cuff may lead to inaccurate hemodynamic measurements.The operators manual instructs the user on these above stated factors that can lead to inaccurate values.It is unknown if user or procedural factors may have contributed to the reported event.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.

• Brand Name: FINGER CUFF
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 6702549
• MDR Text Key: 79969282
• Report Number: 2015691-2017-02001
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2018
• Device Model Number: CSCL
• Device Catalogue Number: CSCL
• Device Lot Number: 60645597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1