MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	30001007201310012
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged while attempting to monitor a patient (age & gender unknown), the device displayed "ecg disabled" and "ecg fault 5" messages.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 was confirmed to be caused by a defective analog board.Further testing of the analog board could not determine the fault.The analog board was replaced to remedy the report.The device was 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: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford WI 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; +1(978)421-9552
• MDR Report Key: 50592058
• Report Number: 1220908-2026-03371
• Device Sequence Number: 10103552
• Product Code: MKJ
• UDI-Device Identifier: 00847946017613
• UDI-Public: (01)00847946017613
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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: Health Professional
• Device Model Number: 30001007201310012
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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