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

Model Number	HEM1
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fda product codes: dqe catheter, oximeter, fiberoptic.Qaq adjunctive predictive cardiovascular indicator.Mud oximeter, tissue saturation.Dxn system, measurement, blood-pressure, non-invasive.Dsb plethysmograph, impedance.Qms adjunctive open loop fluid therapy recommender.Fll thermometer, electronic, clinical.Olw index-generating electroencephalograph software.The device evaluation is anticipated.A supplemental report will be forthcoming when the investigation is completed.The device history record review has not been completed.The device history record was reviewed; no related non-conformances were found.No escalation is required at this time.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, before use, the hemosphere 1 monitor was not giving correct co numbers.The clinician changed cables without resolve.A new monitor worked as expected.It was confirmed that there was no patient involvement associated with the reported issue.
Additional Manufacturer Narrative
A product evaluation was completed on the returned hemosphere 1 monitor.The reported issue could not be confirmed.The evaluation lab was able to obtain normal co reading (~ 7.5 l/min) on module slots 1 and 2 using a swan ganz module and simulator.The co reading remained stable without error for 30 minutes on each module slot.Based on the reported issue there is not sufficient evidence to suggest that the device related issue resulted from any of the specified factors.

• Brand Name: HEMOSPHERE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618
• MDR Report Key: 24011497
• Report Number: 2015691-2026-10271
• Device Sequence Number: 20055823
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)200607
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K243781
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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 Expiration Date: 06/10/2025
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Device Lot Number: 13824913
• Was Device Available for Evaluation?: Yes
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2020
• 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