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

Model Number	30001006001310012
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device lost the ecg signal via electrode pads and the signal did not return.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.Please reference medwatch report number 1220908-2025-00690 for a similar report from the same customer.
Additional Manufacturer Narrative
The device was evaluated by a zoll representative at the customer's facility.The issue occurred when using a standard 3-lead ecg cable with the zoll r series device in proximity to a boston scientific farapulse ablation device.The ecg signal was lost during ablation but reappeared when using monitoring pads or switching modes.The site was using pro pads and a 3-lead cable.The customer noted that this issue occurred only during pulse field ablations the representative identified electromagnetic interference (emi) as the root cause, as the facility was not using an esu filtered ecg cable designed to suppress such interference.It's noteworthy to mention if the r series unit is being used in the presence of an esu, ablation device, or any other high electromagnetic noise emitting source, zoll recommends using the r series 3-lead ecg cable, esu filtered, specifically designed to limit esu artifact when monitoring heart rates.The claim is closed as device meets specification, and customer training has been recommended along with the use of esu filtered 3-lead ecg cables to help reduce electromagnetic noise.No trend is associated with reports of this type.

• 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: 21460256
• Report Number: 1220908-2025-00691
• Device Sequence Number: 7936870
• Product Code: MKJ
• UDI-Device Identifier: 00847946017569
• UDI-Public: (01)00847946017569
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 02/04/2025

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: 30001006001310012
• 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: 02/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2024
• 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