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

Model Number	AED PLUS
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/06/2019
Type of Reportable Event	Death
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 defibrillate a (b)(6) year-old male patient, the device gave a "no shock advised" prompt for a rhythm clinicians believed was shockable.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Device evaluation: the device was not returned to zoll medical corporation for evaluation.Instead, a clinical data file from the reported incident was provided for review.Review of the clinical data file indicated that five out of eight analysis events performed did not meet the criteria for a shockable event due to the ecg being below one hundred microvolts or presence of motion artifacts caused by cpr compressions during an analysis.After review, it was concluded that the device worked as designed and configured and within the limitations of the technology available.This claim has been closed as device meets specification.No trend is associated with reports of this type.

• Brand Name: AED PLUS
• Common Device Name: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 9512982
• Report Number: 1220908-2019-03881
• Device Sequence Number: 16496396
• Product Code: MKJ
• UDI-Device Identifier: 00847946099381
• UDI-Public: 00847946099381
• Combination Product (Y/N): N
• PMA/510(K) Number: K011541/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2019

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: AED PLUS
• Device Catalogue Number: AED PLUS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 60 YR