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

Model Number	HEM1
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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.Patient demographics unable to be obtained.
Event or Problem Description
As reported, when using central venous pressure (cvp) value transferred from mindray monitor, this hemosphere monitor provided high systemic vascular resistance (svr) value.Other mindray analog cables were tested without success.Entering manually the cvp value provided correct svr parameter.No further information available.There was no allegation of patient injury.The device was available for evaluation.Patient demographics unable to be obtained.
Additional Manufacturer Narrative
As per further investigation of this event, it was confirmed that there was an error message displayed when the reported issue occurred.When an error message is displayed, the clinician is alerted of a potential issue, and this will trigger the clinician to conduct routine trouble shooting.If unable to correct, any of the devices that are a part of the system can be replaced with a minor delay in treatment/monitoring.As such, this event is no longer considered reportable and a corrected supplemental report is being submitted.

• Brand Name: HEMOSPHERE ADVANCED MONITOR
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 20357488
• Report Number: 2015691-2024-07540
• Device Sequence Number: 17962888
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)190707
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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 Expiration Date: 07/13/2024
• Device Model Number: HEM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/27/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown