MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION G3 PLUS AUTO, AED, ENGLISH, PKG; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number 9390A-501

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem Necrosis (1971)

Event Type  Death  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that while attempting to defibrillate a (b)(6) male patient, 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 the patient subsequently expired.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaulation.However, visual data of the of the customer's report clinical data was provided by the customer and the device performed to specification.Review of all analysis segments by the clinical group determined that all segments showed an asystole waveform.Asystole, otherwise known as a 'flatline' represents the cessation of electrical and mechanical activity of the heart.Defibrillation therapy is not indicated when this waveform is present.The device determined and made the shock advisory recommendation appropriately based on the input of clinical data from the patient at the time of the analyses.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: G3 PLUS AUTO, AED, ENGLISH, PKG
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• MDR Report Key: 12421071
• MDR Text Key: 269747500
• Report Number: 2112020-2021-00859
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

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
• Device Operator: Other
• Device Model Number: 9390A-501
• Device Catalogue Number: 9390A-501
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 08/16/2021
• Supplement Dates FDA Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 52 YR
• Patient Weight: 181