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	No Information (3190)
Date of Event	06/09/2019
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 while attempting to treat a patient (age (b)(6) and gender male) the device gave a "no shock advised" prompt for a rhythm clinicians believed was shockable.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 not returned, instead the clinical file was returned for investigation.Review of the clinical file from the event determined the algorithm provided the appropriate results.The device worked as designed and intended based on the limitations of the available technology.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: AED PLUS
• Common Device Name: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 8781653
• Report Number: 1220908-2019-01906
• Device Sequence Number: 1999630
• Product Code: MKJ
• UDI-Device Identifier: 00847946099381
• UDI-Public: 00847946099381
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K011541/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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: 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: 06/20/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR