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

Model Number	620-2221011-01
Medical Device Problem Code	Reset Problem (3019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The log of the device was examined, revealing no instances of watchdog resets or unintended shutdowns (payload 0, payload 4, or payload 8).From june 13, 2025, to the present, the device documented only three shutdowns classified as payload 1, all of which were due to the removal of ac power or the battery.The other shutdowns were identified as payload 2 events, resulting from the normal operation of the power button.On june 15, 2026, before the date of the reported event, the device was turned off due to battery removal.The battery linked to the event was not returned for assessment.The log review indicates no evidence of a reset occurring.Furthermore, the device successfully completed all functional tests, including multiple power cycles and bench testing with verified ac power and battery.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device restart/reboot itself multiple times.Complainant indicated that there was no patient involvement in the reported malfunction.

• 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 ; 9784219552
• MDR Report Key: 25779752
• Report Number: 1220908-2026-02358
• Device Sequence Number: 10686464
• Product Code: MKJ
• UDI-Device Identifier: 00847946019143
• UDI-Public: (01)00847946019143
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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: Health Professional
• Device Model Number: 620-2221011-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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