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

Model Number	630-2221111-01
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device was unable to pace.Complainant did not indicate that there was any 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
The device was returned to zoll medical corporation for evaluation.The device logs indicate that the end user initially experienced coupling issues, with the first two pacing attempts generating a "pacer output out of range" message, indicating output is +/- 15% outside specifications.Seconds later, the coupling issue was corrected, and pacing functioned as intended.Review of the device logs identified no system errors or malfunctions.The device was fully evaluated using test accessories, including bench handling and pacer testing with no abnormalities observed, all performance parameters met specifications.The device was recertified and returned to the customer.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: 24162146
• Report Number: 1220908-2026-00114
• Device Sequence Number: 9028909
• Product Code: MKJ
• UDI-Device Identifier: 00847946029524
• UDI-Public: (01)00847946029524
• 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): 01/05/2026

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: 630-2221111-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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