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

Model Number G5A-80P1

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Cardiac Arrest (1762)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

Review of manufacturing records for the serial number shows the device is an automatic aed. The customer purchased the product from a distributor and had wanted to purchase semi-automatic g5 aeds. The aed has been received at cardiac science and will be evaluated. The returned device is labeled as an automatic aed. The customer has been asked to provide additional information about the event and the medic's condition.

Event Description

During a rescue attempt the aed shocked a medic. The customer stated the aed should be a semi-automatic and when using the aed it continues to shock medics. The medic went to a hospital er following delivery of the shock that occurred on (b)(6) 2019.

• Brand Name: POWERHEART G5 AED AUTOMATIC
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR (AED)
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield, wi WI 53531 9692
• Manufacturer (Section G): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield, wi WI 53531 9692
• Manufacturer Contact: margo gisselberg ; 500 burdick parkway; deerfield, wi, WI 53531-9692 ; 2629537950
• MDR Report Key: 9561733
• MDR Text Key: 186745222
• Report Number: 2112020-2020-00001
• 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: other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: G5A-80P1
• Device Catalogue Number: G5A-80P1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 01/07/2020 Patient Sequence Number: 1