MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC HEMOSPHERE ADVANCED MONITORING PLATFORM, HEMOSPHERE FORESIGHT OXIMETER CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	HEMFSM10
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during use in patient, this hemosphere foresight module (fsm) did not measure properly, the values displayed were not as expected according to the physiological status of the patient.The exact values displayed could not be confirmed.The issue was isolated to the fsm after connecting same sensors to different module and correct values were displayed.There was no allegation of patient injury.Patient demographics were requested and unable to be obtained.
Additional Manufacturer Narrative
The product was received by our product evaluation laboratory for a full evaluation.As received, from visual inspection it was detected that some parts of the cable of the foresight module were damaged.It was connected to a known good hemosphere monitor and the measures were properly displayed and values were as expected.After hours taking measures no defects were found.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.
Additional Manufacturer Narrative
Corrected section d7 (single-used device reprocessed and reused on a patient?).The report of incorrect values was not confirmed, since no defect was found as the issue could not be replicated.However, from visual inspection it was detected that the cable of this foresight module was damaged.Based on further engineering investigation performed, physical damage to the cable could potentially be associated to handling of the device by the end user.All events will continue to be reviewed and monitored.

• Brand Name: HEMOSPHERE ADVANCED MONITORING PLATFORM, HEMOSPHERE FORESIGHT OXIMETER CABLE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 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: 20795057
• Report Number: 2015691-2024-09019
• Device Sequence Number: 6990014
• Product Code: DQK
• UDI-Device Identifier: 00690103208573
• UDI-Public: (01)00690103208573(17)261122
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2025

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: HEMFSM10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2024
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown