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.

Manufacturer Narrative

A review of the rescue data downloaded from the aed, which included cardiac science's medical director, determined the aed correctly categorized the patient's rhythm as nonshockable and advised no shock in the first three analysis periods.In the fourth analysis period, the aed detected the patient's svt rhythm as shockable and advised a shock due to the presence of artifact that was most likely due to less than ideal pad placement.This may have been unavoidable due to the anatomy of a 2 month old infant.The delivered shock did not have an adverse effect on the patient's rhythm.The data review determined the aed performed as designed during the event.This event involved a use error.Aeds are indicated for use in the emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing or not breathing normally.The staff attending the patient reported the baby was breathing and had a pulse throughout the time the aed was being used.

Event Description

A two (2) 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
• MDR Report Key: 9462188
• MDR Text Key: 188408896
• Report Number: 2112020-2019-00025
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00812394021185
• UDI-Public: 00812394021185
• Combination Product (y/n): N
• PMA/PMN Number: P160033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G5A
• Device Catalogue Number: G5A-02A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 MO