MAUDE Adverse Event Report: COVIDIEN/CARDINAL HEALTH 200, LLC MEDI-TRACE CADENCE; PACEMARKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON- INVASIVE)

Catalog Number (17)211211

Device Problem Device Emits Odor (1425)

Patient Problem Burn, Thermal (2530)

Event Date 02/13/2020

Event Type  Injury  

Event Description

Scheduled cardioversion.Covidien adult multi-function defibrillation patches were applied anterior/posterior to chest and back and connected to zoll defibrillator, after initial shock o f150 joules and unsuccessful cardioversion, staff noticed a faint burning smell and heard a pop.Pad placement and adherence were checked and agrees to be correctly placed and adhered.Second shock was delivered at 200 joules (cardioversion successful) with similar result of burning smell.After pads were removed, patient was found to have small burn marks on mid chest, none on the back.The prominent burn mark was approx.4 cm long.With several smaller marks scattered where the edge of the pad had been.Silvadene applied to area per physician order.Fda safety report # (b)(4).

• Brand Name: MEDI-TRACE CADENCE
• Type of Device: PACEMARKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON- INVASIVE)
• Manufacturer (Section D): COVIDIEN/CARDINAL HEALTH 200, LLC
• MDR Report Key: 9733423
• MDR Text Key: 180718825
• Report Number: MW5093119
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 30884527022407
• UDI-Public: (01)30884527022407
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2021
• Device Catalogue Number: (17)211211
• 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
• Patient Age: 55 YR
• Patient Weight: 112