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

Model Number	HEMTOM10
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	01/24/2025
Type of Reportable Event	Malfunction
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 results become available.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.
Event or Problem Description
It was reported that a hemtom10 had intermittent connection which caused inconsistent values.During a case, staff noticed the value decrease.It is unknown which hemodynamic value decreased.The issue was resolved by exchanging the module.There were no patient injuries.The device is available for return.
Additional Manufacturer Narrative
A product evaluation was completed on the returned tissue oximetry module.The reported issue was unable to be replicated.The tissue oximetry module was connected to a hemosphere instrument.System verification test ran for 30 minutes and sto2 values remained within parameters for both a and b ports.There were no errors, physical damage, and defect observed.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.No root cause for the reported inaccurate values could be identified since the issue was unable to replicated.A device history record review was completed and documented that device met all specifications upon distribution.

• Brand Name: HEMOSPHERE TISSUE OXIMETRY MODULE
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92604
• Manufacturer (Section G): EDWARDS LIFESCIENCE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21370434
• Report Number: 2015691-2025-00973
• Device Sequence Number: 20962014
• Product Code: MUD
• UDI-Device Identifier: 00690103200355
• UDI-Public: (01)00690103200355(11)210613
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2025

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
• Device Expiration Date: 06/20/2026
• Device Model Number: HEMTOM10
• Device Lot Number: 15707586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown