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U.S. Department of Health and Human Services

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

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CARDIAC SCIENCE CORPORATION POWERHEART G5 AED AUTOMATIC AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
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. ".
 
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Brand NamePOWERHEART G5 AED AUTOMATIC
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATOR
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 Key9225852
MDR Text Key163373007
Report Number2112020-2019-00021
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P160033
Number of Events Reported1
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
1 Patient was Involved in the Event
Date FDA Received10/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG5A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/23/2019 Patient Sequence Number: 1
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