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

Model Number G5A-80A

Device Problem Unintended Electrical Shock (4018)

Patient Problems Death (1802); Electric Shock (2554)

Event Date 07/23/2020

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 patient (age & gender unknown), the device delivered the shock energy to the patient; however the clinician treating the patient also received shock energy as well.Complainant indicated that the patient subsequently expired and that the clinician received an evaluation at the hospital and was cleared.

Manufacturer Narrative

Zoll medical corporation evaluated the device and the device performed to specification.The device was recertified and returned to the customer.The g5 device is available in both fully automatic and semi automatic models.In both models, the device will prompt the user through visual and audible clues.Both units will guide the user through the assessment of the patient and the placement of the pads, will analyze the patient, and instruct the user to "stand clear" during the analysis and to shock if necessary.If the g5 automatic model determines a shock is necessary, an audible countdown begins.During the countdown, the user is warned to "stand back" and the shock is delivered when the countdown is completed.The device will then prompt "shock delivered" and advises when it is safe to start performing cpr.In comparison, the semi-automatic device upon determining a shockable rhythm has been detected will flash the shock button red.The shock is then delivered when the user actuates the shock button.After review of the settings of this device, the voice prompt volume was found to be set on low.This is not the default setting of the device and this setting may have contributed to the user possibly not hearing the appropriate warning prompts from the device.This report has been attributed to usability since the user did not follow or acknowledge the prompts from the device.Analysis of reports of this type has not identified an increase in trend.

• 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
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 10445720
• MDR Text Key: 204157373
• Report Number: 2112020-2020-00653
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 11/19/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death