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

Model Number	1128-001103-01-66
Medical Device Problem Code	Failure to Power Up (1476)
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 would not power up.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the device performed to specification.The device was put through extensive testing including on/off current testing, bench handling, power cycling, and functional stress testing without duplicating the report.The device was recertified and returned to the customer.Review of the device log showed evidence that the device was powered up often into clinical mode and that the device was stored without electrodes.Without electrodes attached will cause the device to remain in the red x condition and emit beep starts to warn the user, which will further drain the battery.The log review supports that the battery became depleted through use and from the device being stored without electrodes connected.Analysis of reports of this type has not identified an increase in trend.

• 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: 22063153
• Report Number: 1220908-2025-01746
• Device Sequence Number: 7812134
• Product Code: MKJ
• UDI-Device Identifier: 00847946026363
• UDI-Public: (01)00847946026363
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/01/2025

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: 1128-001103-01-66
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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