MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT, AUTO, US EN/LA ESP; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number G5A-80A

Device Problems Self-Activation or Keying (1557); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Information (3190)

Event Type  malfunction  

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 patient (age & gender unknown), the device inappropriately delivered energy to the patient, an officer and an ems.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Event Description

Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device self discharged delivering energy to the patient, an officer and an ems person present at the scene.Complainant did not indicate that there was any adverse effect to the patient, officer or ems person due to the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Please reference section b5 and h6; device code.Evaluation results: the device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing without duplicating the report.The device was recertified and returned to the customer.Review of the device activity logs showed that two shocks were observed throughout the event.The first shock was delivered approximately one minute into the case.The user replaced the pads used and once the pads were replaced on the patient the device began a charge cycle and prompted the user to end cpr.Once cpr ended the device began an analysis wherein the device advised of and delivered a shock to the patient.The g5 auto user's manual states that the device will deliver a shock after providing a prompt to the user once the device detects a shockable rhythm.It is unknown which of the 2 shocks the user experienced an inadvertent shock.A fully automatic g5 device requires no user input when charging, analyzing or delivering a shock.The only device prompted patient contact was during the cpr cycle and there were no instances of a shock being delivered while cpr activities were taking place.Per the user's manual, the device is programmed to give a series of prompts prior to the delivery of defibrillation therapy to warn the user.No trend is associated with reports of this type.

• Brand Name: POWERHEART G5 KIT, AUTO, US EN/LA ESP
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• MDR Report Key: 9793999
• MDR Text Key: 187243243
• Report Number: 2112020-2020-00106
• 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: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: G5A-80A
• Device Catalogue Number: G5A-80A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1