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

Model Number	620-2241411-01
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	05/18/2025
Type of Reportable Event	Death
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, which included bench handling and functional testing without duplicating the customer's report.An internal inspection of the power cables and connections within the device found no discrepancies.The device was recertified and returned to the customer.No trend is associated with reports of this type.
Event or Problem Description
Complainant alleged that while attempting to pace a patient during a bradycardia event (age & gender unknown), the device inappropriately shut down.As the patient was being loaded into the back of the ambulance, the patient went into cardiac arrest.The clinician performed resuscitation efforts to continue to treat the patient.The 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: 22168051
• Report Number: 1220908-2025-02053
• Device Sequence Number: 9520496
• Product Code: MKJ
• UDI-Device Identifier: 00847946019372
• UDI-Public: (01)00847946019372
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 05/19/2025

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: 620-2241411-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown