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

Model Number	630-2221212-01
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device failed to discharge.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the customer's report was not replicated or confirmed.The device was put through extensive testing including defibrillation testing and all functional testing without duplicating the report.The device was recertified and returned to the customer.Review of the device activity logs did not show any evidence to support the customer's report.There were no critical errors related to charging or discharging found.One log matched the reported event timeline and showed eight shocks delivered.On the nineth charge, the device was disarmed by the user.As noted in the x series operator's guide, disarming the device can occur if the energy selection is changed, or the device remains charged for over 60 seconds without shock delivery.No trend is associated with reports of this type.

• 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: 22078024
• Report Number: 1220908-2025-01842
• Device Sequence Number: 9501027
• Product Code: MKJ
• UDI-Device Identifier: 00847946029647
• UDI-Public: (01)00847946029647
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/06/2025

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: 630-2221212-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2025
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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