MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZENIX; DEFIBRILLATOR/PACEMAKER

Model Number	1116-321B6B-11-USA-0
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to pace a patient (age & gender unknown), the device was unable to obtain an ecg signal.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to pace a patient (age & gender unknown), the device displayed noisy ecg signal.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
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 section b5.The device was returned to zoll medical corporation for evaluation.The customer reported that during transcutaneous pacing, pacing spikes were displayed without a discernable underlying ecg rhythm, and charging ecg leads did not resolve the issue.Review of the device logs and functional analysis determined that this behavior is consistent with ecg signal artifact during active pacing, where pacing energy delivery, skeletal muscle stimulation, and transthoracic impedance may obscure the underlying ecg waveform.Upon exiting pacing mode, ecg signal presentation returned to baseline, and pacing resumed normally when therapy was restarted.Device operation was consistent with design specifications.No interruption or degradation of pacing therapy delivery was identified, and the issue was limited to ecg waveform visualization during active pacing.The device was recertified and returned to the customer.As a note, events of this nature do not meet zoll's reporting guidelines based on the associated risk of harm.This was inadvertently reported.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ZENIX
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• 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: 24641227
• Report Number: 1220908-2026-01080
• Device Sequence Number: 15892830
• Product Code: MKJ
• UDI-Device Identifier: 00198843003286
• UDI-Public: (01)00198843003286
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/26/2026

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: 1116-321B6B-11-USA-0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2026
• 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