MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE MONITOR; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number HEM1

Device Problem Incorrect Measurement (1383)

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

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.

Event Description

As reported, during use in patient, with this hemosphere monitor, the heart frequency was out of synchronization with the bedside monitor.The heart rate displayed oscillated between 20 and 80 bpm.No error messages were displayed.The patient was not treated with the wrong values since the doctor saw from the beginning the difference of values between both monitors.All the cables were tested and replaced but the issue remained.Once the hemosphere monitor was replaced, the values displayed in both monitors were synchronized again.There was no allegation of patient injury.Patient demographics unable to be obtained.The device was available for evaluation.

Manufacturer Narrative

The hemosphere monitor was received by our technical service center for a full examination.The report of heart frequency out of synchronization could not be confirmed.From visual inspection no defects found.Once received, the device was plugged into the line, the monitor showed good values for heartrate tests.It was not possible to reproduce the issue.Furthermore, the device passed functional test and electrical safety test and and an upgrade to the newest version was performed.The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.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: HEMOSPHERE MONITOR
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 14673683
• MDR Text Key: 293953424
• Report Number: 2015691-2022-06164
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Device Lot Number: 13820929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2019
• 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