MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL ADULT MULTI-FUNCTION ELECTRODES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 8900-4006

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Laceration(s) (1946)

Event Date 04/13/2021

Event Type  malfunction  

Event Description

After synchronized cardioversion at 200j for afib ablation patient had scratch looking red mark in circular pattern in center of chest where zoll pads were removed from.Fda safety report id# (b)(4).

• Brand Name: ZOLL ADULT MULTI-FUNCTION ELECTRODES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 11677879
• MDR Text Key: 246029861
• Report Number: MW5100809
• Device Sequence Number: 1
• Product Code: MKJ
• 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: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2022
• Device Model Number: 8900-4006
• Device Lot Number: 0921A
• 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 Age: 78 YR
• Patient Weight: 82