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

Model Number	90010400499991010
Medical Device Problem Codes	Failure to Power Up (1476); Unexpected Shutdown (4019)
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 during functional testing, the device inappropriately shut down and would not power up.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device is not expected to be returned to zoll for evaluation.A response was received from the customer confirming the issue has been resolved.The reported issue was resolved by the customer by replacing the battery.The customer was contacted about the log and battery to support a more complete evaluation.At this time, no additional information is available.Currently, the status of the device is unknown.This sr will be reopened if the device is returned to zoll for evaluation.

• Brand Name: AED PRO
• 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: 23887625
• Report Number: 1220908-2025-04749
• Device Sequence Number: 15854424
• Product Code: MKJ
• UDI-Device Identifier: 00847946016142
• UDI-Public: (01)00847946016142
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 12/08/2025

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: 90010400499991010
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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