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

Model Number	20000700700011010
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that during functional testing, the device prompted a "unit failed" message.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation following a reported "unit failed" condition.Device logs confirmed error 11 (capacitor failed to charge), along with battery related errors 257,290, and 292.The reported failure was replicated during evaluation.Investigation determined that error 11 is a defibrillator charging failure that triggers a hard failure and causes the device to display a red x status with "change batteries" and "unit failed" messages.The battery coulomb counter reset, eliminating the fault indications.The device successfully completed five monthly tests using the dci panel and operated as expected with ten test duracell batteries.The high voltage capacitor was replaced as a precaution.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: AED PLUS
• 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: 25811836
• Report Number: 1220908-2026-02479
• Device Sequence Number: 17633532
• Product Code: MKJ
• UDI-Device Identifier: 00847946002237
• UDI-Public: (01)00847946002237
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: Other
• Device Model Number: 20000700700011010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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