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

Catalog Number	8900-4006
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was here for a scheduled cardioversion.When the shock button was pushed the anterior defibrillator pad sparked.The patient received a minor burn.He denied pain to staff, burn required no treatment, and patient was discharged home a few hours later.Zoll machine went to biomed who found no issues with the machine and returned it to service.Picture of pad package was taken but actual pads were discarded at the time of the event.

• Brand Name: ZOLL PRO-PADZ ADULT MULTI-FUNCTION ELECTRODES- RADIOLUCENT DEFIBRILLATOR PAD
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; chelmsford ME 01824
• MDR Report Key: 21900731
• Report Number: MW5169495
• Device Sequence Number: 8712763
• Product Code: MKJ
• UDI-Device Identifier: 00847946016661
• UDI-Public: (01)00847946016661(17)260315(10)1125A
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/21/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2026
• Device Catalogue Number: 8900-4006
• Device Lot Number: 1125A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White