MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CABLE ASSEMBLY,EW, ROHS; PX1800 CABLE

Model Number	896083021
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	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were inaccurate values that displayed with the px1800 cable.The blood pressure reading was displaying as 15 to 20mmhg lower than what was being displayed on the philips bedside monitor.The hemosphere instrument could not be ruled out.The report for the hemosphere will be sent under a separate submission.The pressure cables that were being used were new edwards cables.The hypotension was not treated for hours because the blood pressure readings transmitted onto the philips bedside monitor were acceptable.Cables and philips bricks were switched out to resolve the issue.Patient demographics have been requested and not provided.There was no patient harm or injury reported.
Additional Manufacturer Narrative
The px1800 cable has been requested for return for evaluation.It has not yet arrived.Once it has arrived and the product evaluation results are available a supplemental report will be sent with the results.The device history record review was completed and all manufacturing inspections passed with no non conformances.
Additional Manufacturer Narrative
The product was requested for return but did not arrive for evaluation.Without the return of the product, it is not possible to determine if some damage or defect existed on the device that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.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 part of the monthly review.

• Brand Name: CABLE ASSEMBLY,EW, ROHS
• Common Device Name: PX1800 CABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 19715787
• Report Number: 2015691-2024-05246
• Device Sequence Number: 12913693
• Product Code: DXO
• UDI-Device Identifier: 00690103196085
• UDI-Public: (01)00690103196085(17)260126(10)S2208106
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142749
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 01/26/2026
• Device Model Number: 896083021
• Device Lot Number: S2208106
• Was Device Available for Evaluation?: No
• 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: 06/21/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2022
• 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