MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN-GANZ; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	HEMA70CC2
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	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during use, a cco cable had low blood temperature reading and could not calculate co.The cco cable had blood temperature of 89 while the foley catheter had 97.Cable was connected to an alta monitor.There was no patient harm.
Additional Manufacturer Narrative
The device evaluation is anticipated.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
A product evaluation was completed on the returned hema70cc2 cable.The reported event could not be confirmed.Connected the hema70cc2 to an alta monitor 3 times.Each time the cable was recognized and no errors occurred.Moving the cable while connected caused no disconnection or errors.No damage was found.Passed all evaluation steps.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As no defect was found, a product non-conformance or device failure could not be confirmed and no root cause could be determined.In addition, a device history record review was completed and the product passed without nonconformances.

• Brand Name: SWAN-GANZ
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCE; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 23796392
• Report Number: 2015691-2025-10151
• Device Sequence Number: 5520706
• Product Code: DQK
• UDI-Device Identifier: 00690103217704
• UDI-Public: (01)00690103217704(11)250620
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K232294
• 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): 02/23/2026

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
• Device Model Number: HEMA70CC2
• Device Lot Number: 225070320261
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• 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