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

Model Number	1116-121B4B-11-USA-0
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device was unable to pace.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device displayed noisy ecg signal.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference sections b5 and d2.This report was inadvertently submitted.Reports of this nature have no potential impact to patient harm or delay in therapy.The device was returned to zoll medical corporation for evaluation.The complaint describes a condition in which ecg waveform visibility is reduced during active pacing due to tcp signal acquisition characteristics.The condition was limited to displayed artifact only.The device performed as intended with respect to pacing therapy delivery.The observed behavior was transient, detectable, and consistent with expected clinical performance during pacing.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ZENIX
• 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 ; 9784219552
• MDR Report Key: 25079409
• Report Number: 1220908-2026-01710
• Device Sequence Number: 10418392
• Product Code: MKJ
• UDI-Device Identifier: 00198843000063
• UDI-Public: (01)00198843000063(11)2509001
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 1116-121B4B-11-USA-0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2026
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2025
• 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