MAUDE Adverse Event Report: ZOLL FOR VERMED / GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES/VERMED/BIOM DEFIBRILLATION ELECTRODE; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number C100AC-ZOLL

Device Problem Sparking (2595)

Patient Problem Insufficient Information (4580)

Event Date 11/25/2020

Event Type  malfunction  

Event Description

Visible spark noted during elective cardioversion (200j) from anterior proximal aspect of the defib pad where the wires connect to the actual physical pad.There was no gap in adhesion of the pads or other abnormalities noted with the pad upon visual inspection after the single shock delivered.There was a "normal" approximately 3cm x 5cm reddened area in the location of the defib pad contact.Fda safety report id # (b)(4).

• Brand Name: DEFIBRILLATION ELECTRODE
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL FOR VERMED / GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES/VERMED/BIOM; buffalo NY 14204
• MDR Report Key: 11108179
• MDR Text Key: 225173159
• Report Number: MW5098633
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): Y
• 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: 12/29/2020

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 Catalogue Number: C100AC-ZOLL
• Device Lot Number: Y101420-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2020
• 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): Other
• Patient Age: 71 YR