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

Model Number	30001004101110013
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device failed to discharge.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.The customer's report could not be confirmed.The event from (b)(6) 2025, was reviewed using the device log since no clinical file was retained.The log shows two instances where the device was charged and the paddle shock button was pressed, but no shock was delivered due to "poor pad contact" messages.During these attempts, patient impedance was above the valid range, indicating poor coupling between the paddles and the patient.All subsequent shocks that day discharged normally, and the device consistently identified and responded to impedance conditions as designed.No device malfunctions were found.The device will be recertified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: R 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: 23509979
• Report Number: 1220908-2025-04194
• Device Sequence Number: 13178415
• Product Code: MKJ
• UDI-Device Identifier: 00847946017446
• UDI-Public: (01)00847946017446
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/20/2025

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: 30001004101110013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2019
• 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