MAUDE Adverse Event Report: EDWARDS LIFESCIENCES IRVINE HEMOSPHERE FORESIGHT MODULE; OXIMETER, TISSUE SATURATION

Model Number	HEMFSM10
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during use, there was a discrepancy in values with the foresight module.When a sensor was connected to channel 1, the numbers received were in the 70s as expected.The rep switched the sensor to channel 2 and received numbers in the 30s.When they recognized the discrepancy, they performed troubleshooting and exchanged out the module which resolved the issue.There was no inappropriate patient treatment administered nor any patient injury.Patient demographics were requested but not provided.
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.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 a part of the monthly review.
Additional Manufacturer Narrative
One fore-sight elite tissue module was returned for evaluation.The customer report of inaccurate values was unable to be confirmed.Channel 1 and 2 displayed 65% sto2 (+/- 5%) with simulators connected.Moving the cables at no point had an effect on the readings.No errors occurred.The comm cable plug assy was kinked and there was damage near the body of the device.The cable sensors had no physical damage.However, the lower housing was cracked and missing chunks of plastic.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.The report of inaccurate values could not be confirmed, therefore a root cause could not be established.Based on the available information and previous evaluations, there is no evidence that supports or confirms the failure mode is associated to a manufacturing/ design defect.A device history record review was completed and documented that device met all specifications upon distribution.

• Brand Name: HEMOSPHERE FORESIGHT MODULE
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 21710459
• Report Number: 2015691-2025-02316
• Device Sequence Number: 4656347
• Product Code: MUD
• UDI-Device Identifier: 00690103208573
• UDI-Public: (01)00690103208573(17)251104
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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 Expiration Date: 11/04/2025
• Device Model Number: HEMFSM10
• Device Lot Number: 21102165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 06/10/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown