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

Model Number G5A

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Cardiac Arrest (1762)

Event Date 10/16/2019

Event Type  Death  

Manufacturer Narrative

Cardiac science's office in the (b)(6) collected the aed from the customer on (b)(6) 2019.A simulated rescue using an aed simulator was performed at the (b)(6) office and the aed's voice prompts could be clearly heard.Rescue data was downloaded from the aed and will be reviewed.

Event Description

It was initially reported to cardiac science that during a rescue the staff and paramedic were shocked by the aed because none of them heard the aed give prompts that a shock was going to be delivered.More detailed descriptions of the event were provided by two (2) of the medical staff who helped perform the rescue.One of the rescuers reported that after the patient went down she immediately commenced chest compressions while the emergency trolley was fetched and the aed set up.Cpr continued following instruction from the aed.The aed did prompt to stand clear and cpr continued following shock delivery.Later during cpr the patient jumped as he was shocked by the defibrillator.The rescuer was not aware of any change in sensation but jumped back as did the other rescuer.The defibrillator had not prompted the rescuers to stand clear to prepare for shock delivery.Paramedic crews and air ambulance staff took over with als.Following the incident the rescuer was examined and although initially being tachycardic, the ecg was not found to be of concern.The other rescuer reported that cpr was being performed and after applying defibrillator pads the aed prompted shock advised to stand clear.Cpr continued after the first shock was delivered.After changing with a colleague to perform chest compressions, the patient was shocked without the aed giving any warning.The aed was immediately removed and the paramedic's equipment was applied to the patient.After delivery of the shock the rescuer had looked around the room to ensure everyone was not affected by the shock.Cpr was continued.A second paramedic crew and air ambulance crew arrived and care was handed over.Following the rescue attempt the rescuer reported that "both my colleague and i were checked over in the ambulance (ecg's) to ensure we were ok after the defibrillator shock.We both had tachycardia initially (my ecg had ectopics) and no further action was required once our heart rates had returned to normal.".

Manufacturer Narrative

The rescue data file was downloaded from the aed and reviewed.After the lid of the aed was opened and electrodes were attached on the patient, the aed performed four rhythm analysis periods and four cpr sessions.In each of the rhythm analysis periods the aed detected the patient's organized rhythm as nonshockable and advised no shock.The aed started a fifth rhythm analysis period, detected the patient's vf rhythm as shockable and advised and automatically delivered a shock.Prior to the shock, the aed played the prompt "do not touch patient.Analyzing patient" three times.The aed then prompted "shock advised.Do not touch the patient" and before the shock was delivered, the aed played the following prompts, "shock will be delivered in, three, two, one".Following shock delivery the electrodes were removed and the lid of the aed was closed.Review of the rescue data determined the aed worked as designed in the rescue.One shock was administered during the rescue and, prior to shock delivery, the aed provided alerts to notify the users that a shock was going to be delivered.Cardiac science's uk office had performed a simulated rescue and the aed's voice prompts could be clearly heard.Following the data review and per the customer's request, the aed was returned to cardiac science and evaluated.The aed successfully passed testing to factory specifications.The aed will be serviced and returned to the customer.

Event Description

It was initially reported to cardiac science that during a rescue the staff and paramedic were shocked by the aed because none of them heard the aed give prompts that a shock was going to be delivered.More detailed descriptions of the event were provided by two (2) of the medical staff who helped perform the rescue.One of the rescuers reported that after the patient went down she immediately commenced chest compressions while the emergency trolley was fetched and the aed set up.Cpr continued following instruction from the aed.The aed did prompt to stand clear and cpr continued following shock delivery.Later during cpr the patient jumped as he was shocked by the defibrillator.The rescuer was not aware of any change in sensation but jumped back as did the other rescuer.The defibrillator had not prompted the rescuers to stand clear to prepare for shock delivery.Paramedic crews and air ambulance staff took over with als.Following the incident the rescuer was examined and although initially being tachycardic, the ecg was not found to be of concern.The other rescuer reported that cpr was being performed and after applying defibrillator pads the aed prompted shock advised to stand clear.Cpr continued after the first shock was delivered.After changing with a colleague to perform chest compressions, the patient was shocked without the aed giving any warning.The aed was immediately removed and the paramedic's equipment was applied to the patient.After delivery of the shock the rescuer had looked around the room to ensure everyone was not affected by the shock.Cpr was continued.A second paramedic crew and air ambulance crew arrived and care was handed over.Following the rescue attempt the rescuer reported that "both my colleague and i were checked over in the ambulance (ecg's) to ensure we were ok after the defibrillator shock.We both had tachycardia initially (my ecg had ectopics) and no further action was required once our heart rates had returned to normal.".

• Brand Name: POWERHEART G5 AED AUTOMATIC
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• MDR Report Key: 9225852
• MDR Text Key: 163373007
• Report Number: 2112020-2019-00021
• 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

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G5A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death