MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000 CLINICAL PLATFORM NON-INVASIVE (NI) OR CLEARSIGHT SYSTEM; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number PC2K

Device Problem Incorrect Measurement (1383)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

A complete product evaluation and an engineering investigation will be performed in order to consider any potential factor that may have contributed to this complaint.

Event Description

As reported, during the preventive maintenance of this pressure controller kit (pc2k), the measurements at cuff port 1 were not in range for the test at 300mmhg, as the values provided were toggling between 255 and 265 mmhg.There was of error message displayed during this test.There are no patient demographics available since there was no patient involved.This device was available for evaluation.

Manufacturer Narrative

Manufactured and expiration dates were corrected.The manufacturing records were reviewed for the serial number involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.

Manufacturer Narrative

One pressure controller kit was received by technical service center for a further evaluation.The "damaged cuff connector and board" issues were confirmed.When connected to a known working system, no pressure values could be checked with cuff 1, as it did not detect the patient simulator cuff.Additionally, it was found that the connector was pushed back on cuff 1 side, with fractured solder joints, and pads were pulled from the board.The manufacturing records were reviewed for the serial number involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.A root cause for this condition is related to the alignment of pcba mounting to pc2k housing.On the other hand, the number of finger cuff insertion cycles were not defined.Corrective actions have been implemented in order to eliminate the cause of the non-conformity and prevent recurrence of this type of complaint.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 part of this monthly review.

• Brand Name: EV1000 CLINICAL PLATFORM NON-INVASIVE (NI) OR CLEARSIGHT SYSTEM
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 12173677
• MDR Text Key: 261709023
• Report Number: 2015691-2021-04108
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K203131
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/20/2020
• Device Model Number: PC2K
• Device Catalogue Number: PC2K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1