MAUDE Adverse Event Report: EDWARDS LIFESCIENCE PXVFP11298; PRESSURE MONITORING SET

Model Number PXVFP11298

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned for evaluation.When it arrives and the product evaluation has been completed, a supplemental report will be submitted.The device history record review was not completed because no serial number or lot was provided.

Event Description

It was reported that the pressure monitoring set arterial pressure value appeared too high on the philips monitor and was not stable during use.The device was able to be zeroed before use.The customer flushed the device as troubleshooting but the problem was not solved so the device was exchanged.No data log was available.There was no occlusion leakage or kink.The following information could not be obtained the actual value shown on the monitor expected value if the pressure values matched the waveform and if there was an error message.Patient demographic information was requested but unavailable.There were no patient complications reported.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

A supplemental mdr is being submitted due to product evaluation findings.Sections g6, h2, h6: type of investigation, investigation findings, and investigation conclusions have been updated.The pressure monitoring set was returned for evaluation.The dpt zeroed and sensed pressure accurately on the pressure monitor.The pressure did not show any drift during output drift testing.Electrical testing showed that both input impedance and output impedance were within specifications.The zero-offset also met specification.No visible inconsistency was observed from the dpt cable connector.The pressure test was performed at various pressure values and in reverse order with the ge pressure monitor.Visual examinations were performed under microscope at 10x magnification.There was no defect found.

• Brand Name: PXVFP11298
• Type of Device: PRESSURE MONITORING SET
• Manufacturer (Section D): EDWARDS LIFESCIENCE; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCE; edwards lifescience; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; one edwards way; irvine, CA 92614
• MDR Report Key: 18030932
• MDR Text Key: 326865591
• Report Number: 2015691-2023-17147
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

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
• Device Operator: Health Professional
• Device Model Number: PXVFP11298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1