MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED3; DEFIBRILLATOR

Model Number	AED3
Medical Device Problem Codes	Energy Output Problem (1431); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
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 monitor a male patient (age unknown), upon removal of the electrode pads from his chest, the male patient received an unintended delivery of energy.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device discharged while the electrode pads were being removed from the patient.Complainant did not indicate that there was any adverse effect to the patient or clinician due to the reported malfunction.
Additional Manufacturer Narrative
This report was inadvertently submitted as a duplicate.The reported event was originally reported under medwatch 1220908-2023-01821.This supplemental medwatch report is reporting the evaluation of the device and is also correcting information submitted on the initial medwatch report.Please reference section b5 and h6 (medical device problem code).Device evaluation: the device was returned to zoll medical corporation for evaluation.The customer's report was not replicated or confirmed.The device was put through extensive testing including electrical testing and functional testing without duplicating the report.The device was recertified and returned to the customer.Review of the clinical log showed the device is powered on; the pads are adjusted for 2 minutes before an ecg signal is seen.Further motion artifact causes the device to prompt "analysis halted" and delayed the analysis.The analysis starts again but is halted a second time due to the power button being pressed, turning off the device, without finishing an analysis and charge, and with no discharge performed.The evaluation of the log showed the reported sensation was not a clinical discharge from the device.Therefore, our investigation for this reported malfunction was unsubstantiated.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: AED3
• 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: 16860838
• Report Number: 1220908-2023-01562
• Device Sequence Number: 12117733
• Product Code: MKJ
• UDI-Device Identifier: 00847946026363
• UDI-Public: 00847946026363
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/12/2023

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?: Yes
• Operator of Device: Other
• Device Model Number: AED3
• Device Catalogue Number: AED3
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 06/28/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male