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 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.A review of the manufacturing records indicated that the product met specifications upon release.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.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 use on these above stated factors that can lead to inaccurate values.Udi number- (b)(4).

Event Description

It was reported that there was a difference in blood pressure when the clearsight finger cuff measured around 80 to 90mmhg while nibp (manchette) measured around 150mmhg.In addition, there was a difference in the pulse rate when a nihon kohden pulse oximeter measured around 100bpm while around 80bpm was shown from the finger cuff.This was observed when the finger cuff was used during rehabilitation after the off pump bypass surgery to a patient with atrial fibrillation.There was no error messages observed.There were no patient complications reported.The device was discarded by the hospital therefore it is not available for evaluation.Patient demographic information requested but unavailable.

• 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: 6703245
• MDR Text Key: 79969276
• Report Number: 2015691-2017-02004
• 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
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 06/23/2017
• Initial Date FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: No
• 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