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

Model Number	90010400499991010
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device inappropriately shut down.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation and the customer's report was not duplicated.The device was put through extensive testing including functional testing without duplicating the report.Review of the device activity logs did not show "low battery" entries or critical errors.The lack of electrodes connected prevented the device from performing self-tests and detecting a low battery, which contributed to the reported power-off.Electrodes must remain connected at all times otherwise, the device cannot complete self-tests, which can prematurely deplete the battery pack.A new battery pack is recommended.Analysis of reports of this type has not identified an increase in trend.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the device performed to specification.The device passed on/off current testing and stress testing with test batteries.The device was recertified and returned to the customer.The reported condition could not be duplicated.Device logs showed no errors.The returned battery was depleted and failed to power on.The device was used as a primary unit with disposable batteries, which is not ideal for high usage.The customer was advised to transition to rechargeable batteries.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 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: 22819409
• Report Number: 1220908-2025-02999
• Device Sequence Number: 20268442
• Product Code: MKJ
• UDI-Device Identifier: 00847946016142
• UDI-Public: (01)00847946016142
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 07/28/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/19/2025; 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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