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

Model Number	610-2231411-01
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/25/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.During internal inspection, the technician identified loose screws, a damaged side panel, board discoloration, and a broken pemnut consistent with impact damage.This is likely a contributing factor to the customer report and not consistent with typical use.Device history showed no prior service at zoll for this nine plus year old device.Several components were replaced, and cable connections reattached.The device was repaired and passed complete testing.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown) the device displayed a "defib disabled" message.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.

• 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: 24883152
• Report Number: 1220908-2026-01369
• Device Sequence Number: 18756995
• Product Code: MKJ
• UDI-Device Identifier: 00847946004378
• UDI-Public: (01)00847946004378
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 610-2231411-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2016
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown