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

Model Number	30001000301110012
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged while attempting to monitor a 67-year-old male patient, the device inappropriately shut down.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.This is the first of a similar report.The second reported on medwatch 1220908-2026-02913.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

• Brand Name: R SERIES
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; +1(978)421-9552
• MDR Report Key: 50161755
• Report Number: 1220908-2026-02899
• Device Sequence Number: 10603185
• Product Code: MKJ
• UDI-Device Identifier: 00847946017200
• UDI-Public: (01)00847946017200
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 07/20/2026

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: 30001000301110012
• 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: 07/20/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2024
• 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 Age: 67 YR
• Patient Sex: Male