MAUDE Adverse Event Report: EDWARDS LIFESCIENCES IRVINE SWAN-GANZ; COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

Model Number	70CC2
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	10/07/2024
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 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.
Event or Problem Description
It was reported that there was a temperature fluctuation between monitors.The co-cco was not working.The clinician swapped to known working 70cc2 cable using the same monitor and accessories and everything worked correctly.No patient injury was reported, event occurred before use.Additional information was received on 08oct2024: the customer was using a hemosphere.The monitor was displaying temps of 50 and 45 then when they used a different cable the temperature was 35.5.
Additional Manufacturer Narrative
The 70cc2 cable was received.It was found that a fault co: blood temp out of range message is displayed if the cable is bent by the strain relief on the p1 (cco) connector while monitoring.No external damage was found.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Per the results of the product evaluation, the reported event of inaccurate temperature readings could not be confirmed.Additionally, logs were not returned for evaluation.Based on the voc there is not sufficient evidence to suggest that the device related issue resulted from any of the specified factors.Because an error message was displayed when the strain relief was bent during product eval, it is possible that unintended use error contributed to the reported event.However, there is insufficient information to confirm the root cause at this time.A device history record review was completed and documented that device met all specifications upon distribution.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: SWAN-GANZ
• Common Device Name: COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 20510944
• Report Number: 2015691-2024-08012
• Device Sequence Number: 15231459
• Product Code: DXG
• UDI-Device Identifier: 00690103002799
• UDI-Public: (01)00690103002799(17)260301(10)S22901
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K955816
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: 03/01/2026
• Device Model Number: 70CC2
• Device Lot Number: S22901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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