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

Model Number G5A

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

Patient Problem Apnea (1720)

Event Date 11/30/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is in process. Data was downloaded from the aed and is being reviewed.

Event Description

A (b)(6) month old baby was brought into a walk in centre (wic) by the mother. The triage nurse noted the baby was mottled and blue. The nurse took the baby, shouted for help, and an ambulance was called. Baby was having apneic episodes, but a pulse was still present. Nursing staff delivered stimulation to the baby and the baby started to breathe, but was still having apneic episodes; rescue breaths were not administered. Aed pads were applied in the a-p position on the baby and the rhythm analysis stated no shock advised. After approximately seven (7) minutes, the aed analyzed the baby's rhythm, stated shock advised, and a shock was given. The staff reported the baby was breathing and had a pulse throughout the event. The customer wants to know if there was an issue with the analysis of the rhythm and why the aed shocked when it did as there were complexes on the ecg trace. The baby was transferred to the hospital and was still alive when the event was reported to cardiac science.

• 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
• 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: 9462188
• MDR Text Key: 188408896
• Report Number: 2112020-2019-00025
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P160033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: G5A
• Device Catalogue Number: G5A-02A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse