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

Model Number	610-2221011-01
Medical Device Problem Codes	Failure to Charge (1085); Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
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 while attempting to treat a 52 year old male patient, the device failed to charge.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Event or Problem Description
Complainant alleged while attempting to treat a 52-year-old male patient, the device displayed a "defib charging error" message.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.The customer's report could not be duplicated during testing using the returned multifunction cable (mfc) and a known good battery.Review of the device logs from 03/02/2026 identified three charging errors associated with detection of an out-of-spec charging rate, along with a battery calibration required entry.The findings suggest the likely cause of the reported complaint was a battery-related condition.The battery used in the event was not returned for evaluation, despite request.The device was recertified and returned to the customer.Per the surepower ii operator's guide (9650-000840-01 rev.D): users must perform periodic inspection, capacity testing, and functional testing of rechargeable defibrillator batteries to ensure the availability of safe and reliable batteries.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: X SERIES
• 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: 24649637
• Report Number: 1220908-2026-00885
• Device Sequence Number: 15969984
• Product Code: MKJ
• UDI-Device Identifier: 00847946005979
• UDI-Public: (01)00847946005979
• 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): 03/03/2026

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: 610-2221011-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2016
• 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 Age: 52 YR
• Patient Sex: Male