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

Model Number	620-2231511-01
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Death
Event or Problem Description
Complainant alleged that while attempting to treat a female patient (age unknown), the device failed to discharge.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat an 87-year-old female patient, the device failed to discharge.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
This final report is reporting the evaluation of the device and additional information that was received.Please reference section a2, a4, b1, b2, b5, b7, d10-pads info, h1, h6 health effect clinical code, health effect impact code).The device was evaluated by a zoll field service representative at the customer's site.Data file review confirmed that no pads were registered by the device.The device was in a "pads lead fault" state during the attempted discharge, which prevents energy delivery and displays "check pads," per the operator's guide.Field evaluation by zoll confirmed the device functioned as intended and passed all testing within specifications.The pads were disposed of by the customer and investigation closed as no fault found.No trend is associated with reports of this type.

• Brand Name: X SERIES
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; +1(978)421-9552
• MDR Report Key: 24036125
• Report Number: 1220908-2025-04970
• Device Sequence Number: 21096869
• Product Code: MKJ
• UDI-Device Identifier: 00847946019297
• UDI-Public: (01)00847946019297
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 620-2231511-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/09/2026; 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ONESTEP CPR ELECTRODES, PN 8900-0223-01, LOT1525A
• Outcome Attributed to Adverse Event: Death
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 114 LB