MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G5 AED AUTOMATIC; AUTOMATED EXTERNAL DEFIBRILLATOR (AED)

Model Number G5A

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Cardiac Arrest (1762); No Information (3190)

Event Date 04/08/2019

Event Type  Death  

Manufacturer Narrative

The customer was asked to download data from the aed and to provide additional information about the event including if the patient was conscious when the shock was delivered.

Event Description

The customer reported that a g5 automatic aed was used at a gym sometime in (b)(6) 2019 and it was recently determined that the aed shocked the patient while the patient was moving.The customer said the shock may have happened while the patient was being moved onto a stretcher.The outcome of the patient was not reported.

Event Description

The customer reported that a g5 automatic aed was used at a gym sometime in (b)(6) 2019 and it was recently determined that the aed shocked the patient while the patient was moving.The customer said the shock may have happened while the patient was being moved onto a stretcher.The outcome of the patient was not reported.Follow-up report update: additional information about the event was received from a paramedic who was on the scene.The patient was a member of the gym and had a cardiac arrest while on a treadmill.Cpr was in progress and the aed was attached to the patient prior to arrival of the paramedics.The environment was chaotic and very noisy with many bystanders and people still in the gym.Prompts to alert the users not to touch the patient and to alert them a shock was going to be delivered were not heard.According to the paramedic, the patient had been revived (rocs), but then rearrested.Als ceased at the hospital.

Manufacturer Narrative

Corrected data: changed report type from product problem to adverse event.Added adverse event outcome - death.Added date of event.Updated description of the event.Added operator of device.Type of reportable event: changed from malfunction to death.Changed patient code from 3190 to 1762.Evaluation: the rescue data file was downloaded from the aed and sent to cardiac science for analysis.Review of the data determined the aed worked as designed in the rescue.It correctly categorized the patient's rhythm during each rhythm analysis session and delivered shocks when a shockable rhythm was detected.Four (4) shocks had been delivered to the patient before the aed's lid was closed ending the use of the aed in the rescue.

• Brand Name: POWERHEART G5 AED AUTOMATIC
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR (AED)
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• MDR Report Key: 8925811
• MDR Text Key: 155379127
• Report Number: 2112020-2019-00016
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: P160033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: G5A
• Device Catalogue Number: G5A-02C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death