MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PHOENIX DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER-TIP

Model Number PXVP0550

Device Problem Contamination (1120)

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

Event Date 11/30/2023

Event Type  malfunction  

Event Description

It was reported that the customer is unable to zero the transducers.The customer will attempt to zero the transducer on their philips monitor and either will not get a zero or the monitor will show a question mark in the numeric spot with a flat wave line.The customer stated that they will change the dpt and the issue typically resolves.There was no allegation of patient injury.Two separate events occurred on 11/30.Events occurred during setup.Troubleshooting included swapped cables and monitor modules.Lastly swapped transducer setup and everything functioned.There was no patient injury.Products are available for return.The pa line on 1 unit has small piece of unknown object in the middle of the line.Products not available for return.

Manufacturer Narrative

The device will not be returned for evaluation as it was discarded by the customer.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.A supplemental report will be forthcoming with the evaluation and device history results when received.

Manufacturer Narrative

The device was not returned for evaluation.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.Corrections to the h6 type of investigation, investigation findings, and investigation conclusions were made.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 on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.

• Brand Name: PHOENIX DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: TRANSDUCER, PRESSURE, CATHETER-TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18354562
• MDR Text Key: 330871864
• Report Number: 2015691-2023-18522
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 07460691949911
• UDI-Public: (01)07460691949911(17)250901(11)230902(10)65259811
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

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: PXVP0550
• Device Lot Number: 65259811
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2023
• 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