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

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	09/28/2023
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 the pc2k numbers on the hem1 were jumping around while using clearsight.They exchanged the suspect pc2k and the issue was corrected.This was during use.There is no patient injury.Patient demographics were unavailable.
Additional Manufacturer Narrative
The pc2k was received for product evaluation.A visual inspection did not find any visible physical damage.The suspect unit was connected to a hem1 hot mockup system.The connected hrs successfully zeroed.The pc2k caused no errors and was able to acquire a normal waveform and blood pressure readings on both cuff ports.It was monitored on each cuff port for 1 hour and the readings never fluctuated.There was no defect found.

• Brand Name: PRESSURE CONTROLLER KIT
• Common Device Name: PC2K
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: katheryn richards ; one edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 17961657
• Report Number: 2015691-2023-16899
• Device Sequence Number: 5020586
• Product Code: DXN
• UDI-Device Identifier: 00690103193473
• UDI-Public: 0100690103193473
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 11/28/2023

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 Model 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: 09/28/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2021
• 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