MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED 3; DEFIBRILLATOR

Model Number	1128-001103-01
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/16/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device was not returned to zoll medical corporation, instead the activity logs were provided for review.Review of the log file from the reported event concluded that the device worked as designed and within the limitations of the technology.A review of the logs showed successfully completing self-tests in clinical mode, indicating the device was operational and ready for use.Shortly after there was a non-critical error indicating the battery was below the capacity threshold.This suggests the device was operating with a battery that was already nearing depletion prior to the rescue event.The device logged that the button was pressed, released, and the system was powered off while in clinical mode.It appears the device did not shut down unexpectedly or as a result of system failure.The power-off event was user-initiated, and subsequent behavior was consistent with expected device operation under low battery conditions.It's noteworthy to mention according to the zoll aed 3 administrator's guide, the device is capable of delivering at least three maximum energy (200-joule) shocks after a "change battery" message appears.The operator is advised to replace the battery pack as soon as possible once this prompt is displayed.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device inappropriately shutdown.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.

• Brand Name: AED 3
• Common Device Name: DEFIBRILLATOR
• 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: 22852233
• Report Number: 1220908-2025-03069
• Device Sequence Number: 15559024
• Product Code: MKJ
• UDI-Device Identifier: 00847946020071
• UDI-Public: (01)00847946020071
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/01/2025

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: 1128-001103-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown