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

Model Number	8900-4004
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
After two cardioversion attempts on patient, pads were not working and they had a burn smell.Pads removed and new pads were connected to the patient.

• Brand Name: STAT-PADZ
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 milli road; chelmsford MA 01824
• MDR Report Key: 24160744
• Report Number: 24160744
• Device Sequence Number: 15735577
• Product Code: MKJ
• UDI-Device Identifier: 00847946016456
• UDI-Public: (01)00847946016456
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 01/06/2026
• Report Date (Section F): 01/06/2026

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
• Operator of Device: Health Professional
• Device Model Number: 8900-4004
• Device Lot Number: 5025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Date Report Sent to FDA: 01/06/2026