MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PRESSURE CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 70CC2

Device Problem Incorrect Measurement (1383)

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

Event Date 02/22/2023

Event Type  malfunction  

Event Description

As reported, during use in patient with this cco cable, wrong and varying temperature measurements were displayed.Temperature values drifted from 37 celsius to 18 celsius, while peripheral temperature measurement in the bladder remained constant.When the differences between these two measurements were bigger than 2 celsius, the exchange of the cable solved the issue.No error messages were displayed.The patient was not treated according to the wrong values provided.There was no allegation of patient injury.Patient demographics unable to be obtained.The cable was not available for evaluation since it was discarded.

Manufacturer Narrative

The cable involved in this complaint was not available for evaluation since it was discarded at hospital.The serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.Since the affected unit was not returned for evaluation, a product non-conformance or device failure could not be confirmed.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.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.Product not returned for evaluation since it was discarded.

• Brand Name: EDWARDS PRESSURE CABLE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 16573508
• MDR Text Key: 311827296
• Report Number: 2015691-2023-11599
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K191089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70CC2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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