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

Model Number	620-0221510-01
Medical Device Problem Codes	Intermittent Loss of Power (4016); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to monitor a patient (age & gender unkown), the device inappropriately shut down.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Event or Problem Description
Complainant alleged that while attempting to monitor a patient (age & gender unkown), the device restart/reboot itself multiple times.
Additional Manufacturer Narrative
Justification for no udi, information was not provided and is unknown ; therefore, a complete udi cannot be provided.Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
This supplemental report is reporting the evaluation of the device and correcting information submitted on the initial report.Please reference b5, d1, d4 and h6: event description, brand name, model #, serial #, primary udi #, and medical device problem code the device was returned to zoll medical corporation for evaluation.The customer's report was observed during review of the device data logs.However, the device was put through extensive testing including bench handling, defib function cycling, all functional testing and power cycling with battery and aux separately and together without duplicating the report.The monitor board was replaced as a precaution.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

• 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: 50072065
• Report Number: 1220908-2026-02822
• Device Sequence Number: 10361679
• Product Code: MKJ
• UDI-Device Identifier: 00847946018740
• UDI-Public: (01)00847946018740
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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: 620-0221510-01
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 07/07/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown