MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMPUTER DIAGNOSTIC, PROGRAMMABLE; CLEARSIGHT MODULE

Model Number HEMCSM10

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/05/2023

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 completed and all inspections passed with no non-conformances.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.H3 other text : awaiting device return.

Event Description

It was reported that the hemcsm10 blood pressure reading is inconsistent.The blood pressure readings were sporadic in that the systolic would become low then increase quickly without any interventions.It continued to happen so staff checked placement of the cuff made sure no lines were kinked and the hrs was re-zeroed.No damage was noted.This was during use.There was no inappropriate treatment administered and patient demographics were available.

Manufacturer Narrative

A supplemental mdr is being submitted due to product evaluation findings.Sections g6, h2, h6: type of investigation, investigation findings, and investigation conclusions have been updated.One hemcsm10 was received for product evaluation.The suspect hemcsm10 was connected to a known working hem1 hot mock-up system.The hemcsm10 caused no errors.It was also able to obtain normal blood pressure readings and waveform.The hemcsm10 was ran for half an hour without any errors.No damage was found.There was no defect.

• Brand Name: COMPUTER DIAGNOSTIC, PROGRAMMABLE
• Type of Device: CLEARSIGHT MODULE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwdards way; irvine CA 92614
• Manufacturer Contact: katheryn richards ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18314993
• MDR Text Key: 330569877
• Report Number: 2015691-2023-18324
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103202762
• UDI-Public: (01)00690103202762(11)210304
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203687
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEMCSM10
• Device Lot Number: 16800882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2021
• 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