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

Model Number	30001004101110013
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock (2072)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the device performed to specification.On (b)(6) 2025, the r series delivered a shock while in manual mode.Device logs confirmed that the user manually selected the 30 joules, charged the device, and pressed the shock button, resulting in the delivery of 35.4 joules at a patient impedance of 74.5 ohms.The r series requires full operator control in manual mode and cannot deliver shocks autonomously.The device and accessories passed full functional testing with no faults or malfunctions.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that while attempting to monitor a 50-year-old male patient, the patient received an unintended delivery of energy.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

• 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: 21875965
• Report Number: 1220908-2025-01359
• Device Sequence Number: 7899755
• Product Code: MKJ
• UDI-Device Identifier: 00847946017446
• UDI-Public: (01)00847946017446
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/31/2025

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: 30001004101110013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2017
• 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: Other
• Patient Age: 50 YR
• Patient Sex: Male