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

Model Number HEM1

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Event Description

As reported, during a preventive maintenance at the hospital of this hemosphere monitor, it was found that inaccurate heart rate values were provided, heart rate values drifted.Expected values were 60bpm and values provided were higher, around 135 bpm.Additionally, the bezel alarm cover was missing.Customer did not report any failure regarding this monitor before the maintenance.No patient was involved.The device was available for evaluation.

Manufacturer Narrative

Upon the return of the product an investigation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.The manufacturing records were reviewed for the lot involved 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.

Manufacturer Narrative

Added information to section d4 (expiration date) and h4 (device manufacturer date), h6 (type of investigation).Updated section h6 (component code), h6 (health effect), h6 (investigation findings) and h6 (investigations conclusions).The hemosphere monitor was received by out technical service center for a full examination.The reported issue of inaccurate values was unable to be reproduced and no values were obtained instead.From visual inspection it was confirmed that the led alarm cover was missing and the service kit bezel alarm was replaced.The monitor was powered up and ecg simulator was connected.The message "ecg input connected" was not shown and no values were displayed.Then, 70anhs cable was connected to analog ports 1 and 2 but no signal could be detected.Firstly, it was tried to replace the analog wifi pcba, but the issue persisted.Then, the original pcba was reinstalled and backplane was replaced.After that, the issue was solved.Furthermore, based on additional testing performed by the original manufacturer the ecg port failed functional tester.Despite no defect was found on the port the component was replaced.After the repair, the monitor was tested according to internal procedures and it passed all the tests.Based on further engineering investigation, no root cause for the issue of the reported inaccurate values could be determined since the issue was not able to be reproduced during the product evaluation.The cause of the functional issues identified during product evaluation appears to be related to a backplane component failure as the issues were resolved replacing the backplane.The issue of physical damage on the alarm cover is consistent to be related to the handling of the device by the end user.

• Brand Name: HEMOSPHERE ADVANCED MONITOR
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 17794538
• MDR Text Key: 324231236
• Report Number: 2015691-2023-16080
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HEM1
• Device Lot Number: 13823660
• 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: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1