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

Model Number	PC2K
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	01/26/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 2015691-2022-03948
• Device Sequence Number: 14831535
• Product Code: DXN
• UDI-Device Identifier: 00690103193473
• UDI-Public: 0100690103193473
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140312
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2022

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: 01/26/2022
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 03/17/2022; 09/09/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 03/24/2022; 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2017
• 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