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

Model Number	22800810102011010
Medical Device Problem Codes	Unable to Obtain Readings (1516); Failure to Analyze Signal (1539); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device did not operate correctly.At this time, no additional information is available.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired, however it was not a result of the reported malfunction.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section a2, b5, d4 serial # and primary udi # and h6 (medical device problem code) updated.The device is returned to zoll medical corporation for evaluation.The device passed all functional testing with no faults found.No electrode pads were returned with the device.The device only records a clinical file when patient impedance is detected.The customer reported "check pads" messages and inability to analyze, which is consistent with poor electrode coupling and absence of measured patient impedance.Device history indicated multiple successful monthly self-tests and a green check status prior to the event.Both the reported "check pads" message and inability to analyze are consistent with poor pad-to-patient coupling; however, this could not be confirmed because the pads were not returned.No additional information regarding patient skin preparation was available.Overall evaluation found the device functioning as designed with no fault identified.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 that while attempting to treat a 71-year old male patient, the device displayed a "check pads" message and was unable to analyze.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired, however it was not a result of the reported malfunction.

• Brand Name: AED PLUS
• 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: 24026979
• Report Number: 1220908-2026-00104
• Device Sequence Number: 21481483
• Product Code: MKJ
• UDI-Device Identifier: 00847946056421
• UDI-Public: (01)00847946056421
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: 22800810102011010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 71 YR
• Patient Sex: Male