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

Model Number	610-2221410-01
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation.The customer report was unable to be duplicated during functional inspection.The device was extensively tested to clincial extremes and passed successfully.The device log was reviewed and it appears the connection between the device and the multifunction cable (mfc) was intermittent at times as a factor in the customer report.The defib receptacle was replaced as a precaution, and a new mfc cable was sent to the customer.The device was recertified and returned to the customer.No emerging trend based on similar reports.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device experienced ecg monitoring failure.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: 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: 24899109
• Report Number: 1220908-2026-01403
• Device Sequence Number: 18304285
• Product Code: MKJ
• UDI-Device Identifier: 00847946005986
• UDI-Public: (01)00847946005986
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/23/2026

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: 610-2221410-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2015
• 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