MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PRO PADZ; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number	8900-4006
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Shock from Patient Lead(s) (3162)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient in for an elective cardioversion.Patient shaved prepped and dried, good adhesion with pads to skin.The patient was shocked using external synchronized biphasic shock with 200 joules.A spark was noted by staff during biphasic shock at the anterior defib pad location and pads immediately removed, burned hair and possible 1st degree burn at site of anterior pad.The shock was successful, md evaluated site, patient recovered and discharged home later same day.

• Brand Name: PRO PADZ
• Common Device Name: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 24230467
• Report Number: 24230467
• Device Sequence Number: 18688930
• Product Code: DTE
• UDI-Device Identifier: 00847946016661
• UDI-Public: (01)00847946016661(17)260719(10)2925A
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/20/2026
• Report Date (Section F): 01/20/2026

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 Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Device Lot Number: 2925A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/02/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/20/2026