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

Model Number	620-0221511-01
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged while attempting to monitor a patient (age & gender unknown), the device inappropriately delivered energy to the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Event or Problem Description
Complainant alleged while attempting to monitor a patient (age & gender unknown), a conscious patient received an unintended delivery of energy.
Additional Manufacturer Narrative
This supplemental report is reporting the evaluation of the device and correcting information submitted on the initial report.Please reference b5 and h1: incident description and type of reportable event the device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing including bench handling, defib testing, and hot/cold testing without duplicating the report.However, review of the log identified one instance of a 30j shock being delivered to a patient on event date (b)(6) 2026.The device is not designed to deliver a shock by itself and requires manual input for shock to be delivered.From the logs, we also identified 30j test shock being delivered to a patient instead of a short circuit of the patient leads.The customer was contacted to share results of the log review and to review x series operator's guide for proper test set-up.This investigation is closed as device used incorrectly.The device was recertified and returned to the customer.No trend is associated with reports of this type.
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

• 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: 50278782
• Report Number: 1220908-2026-03080
• Device Sequence Number: 10267738
• Product Code: MKJ
• UDI-Device Identifier: 00847946018757
• UDI-Public: (01)00847946018757
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P160022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2026

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: Other
• Device Model Number: 620-0221511-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2026
• 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: 07/30/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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
• Patient Sex: Unknown