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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 (AED)

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CARDIAC SCIENCE CORPORATION POWERHEART G5 AED AUTOMATIC AUTOMATED EXTERNAL DEFIBRILLATOR (AED) Back to Search Results
Model Number G5A-80P1
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Cardiac Arrest (1762)
Event Date 12/12/2019
Event Type  malfunction  
Manufacturer Narrative
Review of manufacturing records for the serial number shows the device is an automatic aed. The customer purchased the product from a distributor and had wanted to purchase semi-automatic g5 aeds. The aed has been received at cardiac science and will be evaluated. The returned device is labeled as an automatic aed. The customer has been asked to provide additional information about the event and the medic's condition.
 
Event Description
During a rescue attempt the aed shocked a medic. The customer stated the aed should be a semi-automatic and when using the aed it continues to shock medics. The medic went to a hospital er following delivery of the shock that occurred on (b)(6) 2019.
 
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Brand NamePOWERHEART G5 AED AUTOMATIC
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATOR (AED)
Manufacturer (Section D)
CARDIAC SCIENCE CORPORATION
500 burdick parkway
deerfield, wi WI 53531 9692
Manufacturer (Section G)
CARDIAC SCIENCE CORPORATION
500 burdick parkway
deerfield, wi WI 53531 9692
Manufacturer Contact
margo gisselberg
500 burdick parkway
deerfield, wi, WI 53531-9692
2629537950
MDR Report Key9561733
MDR Text Key186745222
Report Number2112020-2020-00001
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberG5A-80P1
Device Catalogue NumberG5A-80P1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/07/2020 Patient Sequence Number: 1
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