MAUDE Adverse Event Report: Edwards Lifesciences 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)
Type of Reportable Event	Malfunction

• Brand Name: HEMOSPHERE FORESIGHT MODULE
• Common Device Name: Oximeter, Tissue Saturation
• Manufacturer (Section D): Edwards Lifesciences; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer (Section G): Edwards Lifesciences; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; +1(949)201-7706
• MDR Report Key: 50923064
• Report Number: 2015691-2026-18905
• Device Sequence Number: 5804423
• Product Code: MUD
• UDI-Device Identifier: 00690103208573
• UDI-Public: (01)00690103208573(11)230607(2
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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?: Yes
• Date Returned to Manufacturer: 09/16/2026
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2023
• 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): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown