MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, DR PRESSURE MONITORING SET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number DPT UNKNOWN

Device Problem Incorrect Measurement (1383)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the icu is experiencing inaccurate values with px284 or pxvp2284.It is unknown how many events for each dpt occurred.No additional information was provided.This report was received following previous complaints of inaccurate values (2023-28249).Follow-up is ongoing for additional details.It is unknown at this time if the device is available for return.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Manufacturer Narrative

H3 other text : unknown if device is available for return.

• Brand Name: PRESSURE MONITORING SET
• 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 ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES, DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 18975956
• MDR Text Key: 339156327
• Report Number: 2015691-2024-02299
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/25/2024

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 Model Number: DPT UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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