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

Model Number	610-2221011-01
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.Device evaluation did not confirm the reported failure to charge.Functional testing with a known good battery successfully charged and discharged.The event battery was not returned as part of the investigation.The device logs identified a defibrillator charge timeout at 200 j setting and battery calibration required messages.The battery advisory indicates the battery required calibration which is a process to align battery capacity with the runtime.Log review further supports that the battery was likley depleted since it was able to charge and deliver a shock at 120j.Further review of the logs support the device functioned as expected with a charged battery.The device was recertified and returned to the customer.No trend is associated with reports of this type.
Event or Problem Description
Complainant alleged while attempting to treat a patient (age & gender unknown), the device failed to charge.Complainant did not indicate that there was any adverse effect to the patient due to 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: 25873759
• Report Number: 1220908-2026-02473
• Device Sequence Number: 10618386
• Product Code: MKJ
• UDI-Device Identifier: 00847946005979
• UDI-Public: (01)00847946005979
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/22/2026

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: 610-2221011-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 07/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2015
• 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