MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL PRO-PADZ; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Lot Number 0819

Device Problem Device Emits Odor (1425)

Patient Problem Burn, Thermal (2530)

Event Date 03/11/2019

Event Type  malfunction  

Event Description

A cath lab pt sustained a small burn under the pad site used for cardioversion.The pt was undergoing an afib cryo ablation.A zoll pad was placed on the left lateral chest of the pt.Cardioversion was attempted at 14:33 and again 14:34.At 15:20, the left lateral pad was removed and a new zoll pad was placed on the left anterior chest.At 15:24, another cardioversion was attempted.At 15:25, the team noticed a "burnt" smell and discovered a small circular burn under the zoll pad.The physician examined the site and noted that it looked like a small "rash." the pt denied pain post procedure and when the site was checked several hours later, the pt denied pain or discomfort.The pads were not expired and/or dried out and there were no ripples or bubbles underneath the pad.The pad was not placed on a tattoo and it was the correct pad for the procedure.The vendor was also notified of this event.Fda safety report id # (b)(4).

• Brand Name: ZOLL PRO-PADZ
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; chelmsford MA 01824
• MDR Report Key: 8565102
• MDR Text Key: 143678985
• Report Number: MW5086259
• Device Sequence Number: 1
• Product Code: MKJ
• 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: 04/25/2019

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 Expiration Date: 02/23/2020
• Device Lot Number: 0819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2019
• 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: 76 YR
• Patient Weight: 99