MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G3 PLUS AUTOMATIC AED; AUTOMATED EXTERNAL DEFIBRILLATOR (AED)

Model Number 9390A

Device Problems Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Cardiac Arrest (1762)

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

Data from the rescue event was downloaded from the aed by the customer and sent to cardiac science for analysis.Clinical and technical reviews of the rescue data determined the aed correctly categorized the patient's vf rhythm in the first analysis session as shockable and delivered a shock which successfully restored the patient's rhythm.In the second analysis session, the aed incorrectly categorized the patient's non-shockable rhythm as shockable due to tall t waves in the sinus rhythm and a shock was delivered.The shock had no effect on the patient's rhythm and appeared to do no harm.

Event Description

The patient collapsed shortly after expressing thoughts of not feeling well.Cpr was started.After the aed arrived, the electrodes were placed on the patient and a shock was advised and delivered.Soon thereafter, the patient began grunting and moaning.According to the athletic trainer, the aed advised and delivered a second shock while the patient was becoming alert.The pads were removed and the ems took over care of the patient.The patient was alert when the ems took control.The patient survived.

• Brand Name: POWERHEART G3 PLUS AUTOMATIC AED
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR (AED)
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• Manufacturer (Section G): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• Manufacturer Contact: margo gisselberg ; 500 burdick parkway; deerfield, WI 53531-9692 ; 2629537950
• MDR Report Key: 8708149
• MDR Text Key: 148308578
• Report Number: 2112020-2019-00014
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9390A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening