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

Model Number	HEMOXSC100
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for analysis; however, it has not been evaluated yet.Upon the evaluation of the product a supplemental report will be sent with the investigation results.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.
Event or Problem Description
As reported, this hemosphere oximetry cable provided different measurements than expected according to physiological state of the patient.The issue was solved replacing the device.There was no further information available.There was no allegation of patient injury.
Additional Manufacturer Narrative
The device was received for evaluation.The report could not be confirmed for the reported issue.From visual inspection, no defects were found on the oximetry cable.As received, the cable was plugged into the known good unit hemosphere monitor and in vitro calibration was performed according to internal procedures.No errors appeared during in 24 hours.In addition, the device was tested in the functional test and it passed successfully.The manufacturing records were reviewed for the serial number involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Based on further engineering evaluation, the root cause of inaccurate values cannot be determined at this time since the issue of inaccurate values cannot be replicated during device evaluation.Patient demographics unable to be obtained.

• Brand Name: HEMOSPHERE OXIMETRY CABLE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 21122425
• Report Number: 2015691-2025-00212
• Device Sequence Number: 7538774
• Product Code: DQK
• UDI-Device Identifier: 00690103196986
• UDI-Public: (01)00690103196986(11)230830
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213682
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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
• Operator of Device: Health Professional
• Device Model Number: HEMOXSC100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown