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

Model Number 8900-4006

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

Patient Problem Burn, Thermal (2530)

Event Date 12/19/2018

Event Type  malfunction  

Event Description

Patient was cardioverted and pads were removed.Patient converted back into a atrial fib and new pads were placed and the patient was cardioverted again.When removing the pads the second time it was noted that the patient was burnt and the patient had a burnt smell.

• Brand Name: PRO-PADZ
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION ; 269 mill rd; chelmsford MA 01824 4105
• MDR Report Key: 8217374
• MDR Text Key: 132342387
• Report Number: MW5082833
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2019
• Device Model Number: 8900-4006
• Device Catalogue Number: 00847946016661
• Device Lot Number: 4718A
• Is the Reporter a Health Professional?: No
• 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: 65 YR
• Patient Weight: 75