MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE; HEMOSPHERE SWAN-GANZ MODULE

Model Number	HEMSGM10
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	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda product codes include dqk computer, diagnostic, programmable.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.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.The device history record review was completed and no related non-conformances were found.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
As reported during use the hemosphere swan ganz module was giving incorrect values.A new module worked as expected.No damage was noted.There was no additional information.There was no patient injury.The device is available for evaluation.
Additional Manufacturer Narrative
One hemosphere swan ganz module was returned for evaluation.The issue of inaccurate values was unable to be replicated.When this module was placed in a known working hemosphere monitor, no values could be obtained due to it causing a fault for ""hardware failure."" no faults were present when a known working board was used.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/ design defect.The swan ganz mainboard was defective.The failure is consistent with component failure.

• Brand Name: HEMOSPHERE
• Common Device Name: HEMOSPHERE SWAN-GANZ MODULE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 17200 laguna canyon rd; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 21935630
• Report Number: 2015691-2025-03394
• Device Sequence Number: 17450286
• Product Code: DQE
• UDI-Device Identifier: 00690103196993
• UDI-Public: (01)00690103196993(11)180623
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K163381
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 07/11/2023
• Device Model Number: HEMSGM10
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2018
• 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