MAUDE Adverse Event Report: COVIDIEN ADULT MULTI-FUNCTION DEFIBRILLATION ELECTRODES; PACEMAKER, CARDIAC, EXTERNAL, TRANSCUTANEOUS

Catalog Number 22550A

Device Problems Intermittent Continuity (1121); Device Displays Incorrect Message (2591); Device Sensing Problem (2917)

Patient Problem No Code Available (3191)

Event Date 11/14/2018

Event Type  Injury  

Event Description

Defib patches are not functioning correctly.When first applied the patches are recognized by the defibrillator and a rhythm is displayed.Intermittently the rhythm is lost and the defibrillator says "connect electrodes".This has happened on multiple defibrillators but seems to happen with the specific "covidien medi-trace cadence" brand of patches.

• Brand Name: ADULT MULTI-FUNCTION DEFIBRILLATION ELECTRODES
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL, TRANSCUTANEOUS
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 8077989
• MDR Text Key: 127892258
• Report Number: MW5081356
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2020
• Device Catalogue Number: 22550A
• Device Lot Number: 821838X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention