MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMCSM10; CLEARSIGHT MODULE

Model Number HEMCSM10

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned for evaluation.When it arrives and the product evaluation has been completed, a supplemental report will be submitted.The device history record review was not completed but will be provided after it has been finished.

Event Description

It was reported in the hemcsm10 that hemodynamic malfunctions were noticed on a live demo in which the clearsight cuff was placed on a few doctors in which all ci values appeared lower than expected and were suggestive of heart failure when they were confirmed as healthy.This system was not used on a patient.Demographics were not available.There will be no product return as logs were sent in to be evaluated.

Manufacturer Narrative

The product was not returned for evaluation.The logs that had been sent in were corrupted and the data was unable to be read.The device history record review was completed and all inspections passed with no non-comformances.

Manufacturer Narrative

Logs were not received for this complaint.H3 other text: product not returned.

• Brand Name: HEMCSM10
• Type of Device: CLEARSIGHT MODULE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; one edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 12416784
• MDR Text Key: 270366606
• Report Number: 2015691-2021-04824
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)201226(2
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2022

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 Model Number: HEMCSM10
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 09/09/2021; 12/10/2021
• Supplement Dates FDA Received: 09/22/2021; 01/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2020
• 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