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

Model Number	1128-001103-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to treat a male patient (age unknown), the electrode pads would not adhere to the patient's skin.Complainant indicated that the clinician obtained another set of pads to continue treating the patient.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The product has not been returned to zoll for evaluation, and the tracking confirms the pads remain at the customer site.If returned, they will be evaluated and documented.The customer reported that the patient had flaky skin and no skin preparation, which may have contributed to poor pad adhesion.A review was conducted of the device history record (dhr) for the electrode lot associated with this complaint.The review found no abnormalities.Incoming inspection results for the foam lot met specifications.Evaluation of a retain sample from the electrode lot confirmed proper pad adhesion as intended.No trend is associated with reports of this type.

• 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: 23403034
• Report Number: 1220908-2025-03976
• Device Sequence Number: 13229508
• Product Code: MKJ
• UDI-Device Identifier: 00847946000189
• UDI-Public: (01)00847946000189(17)270512(10)0722A
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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: Other
• Device Model Number: 1128-001103-01
• Was Device Available for Evaluation?: No
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CPR-D PADS, LOT# 0722A
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male
• Patient Race: White