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

Model Number	1116-111047-21-USA-0
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 during functional testing, the device would not power up.Complainant did not indicate that there was any patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation.The history log from this device was reviewed for evidence of the device not powering on and any other power-related, battery, or ac faults.There are no power-related faults closer to the aware date of 06/29/2026, despite the device continuing to be used by the customer.The device returned by the customer underwent testing without duplicating the customer's report.The device was able to power on with multiple known good accessories, including the customer's returned battery (sn (b)(6)).The battery itself passed functionality testing as well and was successfully recalibrated.There was no fault found with the device.The device was recertified and returned to the customer.Analysis for 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 ; +1(978)421-9552
• MDR Report Key: 25870232
• Report Number: 1220908-2026-02558
• Device Sequence Number: 12788055
• Product Code: MKJ
• UDI-Device Identifier: 00198843000346
• UDI-Public: (01)00198843000346(11)260401
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 06/29/2026

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: 1116-111047-21-USA-0
• Date Returned to Manufacturer: 07/08/2026
• 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: 06/29/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2026
• 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