MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED 3; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	1128-001102-01
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant alleged while attempting to treat a patient (age & gender unknown), the device self-discharged.It is unknown whether the event resulted in harm to the patient or clinical staff.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.A review of the clinical log dated 07/24/2026 identified no critical errors.The device powered on, completed the rescue sequence, remained operational for approximately 25 minutes, and delivered eight shocks at 120 j, 150 j, and 200 j.Patient impedance ranged from 81-93 ohms.Given that the device automatically analyzes the patient's ecg and determines whether a shockable rhythm is present, the operator could not control when shocks were advised; therefore, the customer report could not be duplicated.The device performed as expected and designed in this setting.Functional testing with test batteries was completed successfully, and inspection found no device faults.The unit will be recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: AED 3
• 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: 50882106
• Report Number: 1220908-2026-03694
• Device Sequence Number: 21509909
• Product Code: MKJ
• UDI-Device Identifier: 00847946020064
• UDI-Public: (01)00847946020064
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P160015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial

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: 1128-001102-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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: Other
• Patient Sex: Unknown