MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PC2K; PRESSURE CONTROLLER KIT

Model Number PC2K

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

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

Event Date 01/26/2022

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 review was completed and all inspections passed with no nonconformances.

Event Description

It was reported that one of the pc2k cuffs is not working.The patient cuff is reading a blood pressure of 130 over 80 but this pc2k is showing a low reading of 90 over 60.The clinician exchanged to a known working pc2k using the same monitor and accessories and everything works.This was during use.There is no patient injury.There were no error messages.Patient demographics were unavailable.

Manufacturer Narrative

After several attempts made to request product return from the customer, there was no response received.The product was not returned for evaluation.If the product does arrive, a supplemental report will be submitted with the evaluation findings.H3 other text : device not returned.

Manufacturer Narrative

One pressure controller was returned for evaluation.When testing the pressure controller, they could not connect to either cuff port.A visual inspection found that both connectors were damaged with fractured solder joints and damaged pads.

• Brand Name: PC2K
• Type of Device: PRESSURE CONTROLLER KIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; one edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 13529463
• MDR Text Key: 285741921
• Report Number: 2015691-2022-03948
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00690103193473
• UDI-Public: 0100690103193473
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2022
• Device Model Number: PC2K
• Device Catalogue Number: PC2K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1