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

Model Number	30001003101110012
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.Log data showed that on the reported event date, multiple successful discharges were delivered at 120 j and 200 j.At approximately 15:59, the device was charged and placed into sync mode.The device displayed a "remove sync" prompt, indicating sync mode was active when attempting to use the analyze feature by design.Users subsequently pressed the shock button multiple times without energy delivery.A successful 120 j shock was eventually delivered several seconds later.Review of the event data indicates the device remained in sync mode, which requires the shock button to be pressed and held until energy delivery occurs.The device provided visual prompts and sync markers to indicate sync mode status.Device testing was performed and passed successfully.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 while attempting to treat a 65-year-old female patient, the device failed to discharge.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.

• 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 ; 9784219552
• MDR Report Key: 25456362
• Report Number: 1220908-2026-01992
• Device Sequence Number: 8725596
• Product Code: MKJ
• UDI-Device Identifier: 00847946017392
• UDI-Public: (01)00847946017392
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/20/2026

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: 30001003101110012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 65 YR
• Patient Sex: Female