MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CC TRUWAVE CABLES 896 SERIES; PX1800

Model Number PX1800

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

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

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

The cc truwave cables 896 series was not returned as the unit had been discarded.The device history review could not be completed because no serial number was provided.The udi number is not available because no serial number was provided.

Event Description

It was reported that the cc truwave cables 896 series had a drift in results in the icu.They do not have a complete picture as to the incidence at this time but they have been able to verify drift after about 1 hour on a simulator in clinical engineering.This was before use.There is no patient injury.There will be no product return as the cable was discarded.

• Brand Name: CC TRUWAVE CABLES 896 SERIES
• Type of Device: PX1800
• 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: 13194081
• MDR Text Key: 285746616
• Report Number: 2015691-2022-03272
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2022

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
• Device Operator: Health Professional
• Device Model Number: PX1800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: No
• 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