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

Model Number	630-2221112-01
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2026
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 and the device intermittently would not display a ecg signal.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The customer provided a tracking number indicating the device was received at zoll; however, the device could not be located upon internal search of service depot, warehouse, and receiving records.Despite thorough investigation by logistics and receiving, the device remains missing.A replacement device was approved and issued to the customer.As the device was unavailable for evaluation, the complaint was closed as "information not sufficient for investigation." if the device is later located, the claim will be reopened for investigation.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: 24607016
• Report Number: 1220908-2026-00961
• Device Sequence Number: 10343623
• Product Code: MKJ
• UDI-Device Identifier: 00847946029623
• UDI-Public: (01)00847946029623
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/25/2026

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: 630-2221112-01
• Was Device Available for Evaluation?: No
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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