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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION G3 PLUS, AED, AHA 2010, ENGLISH AUTOMATED EXTERNAL DEFIBRILLATOR

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CARDIAC SCIENCE CORPORATION G3 PLUS, AED, AHA 2010, ENGLISH AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number 9390E-1001
Device Problems Self-Activation or Keying (1557); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that while attempting to defibrillate a male patient (age unknown), the device self discharged and the rescuer received an unintended delivery of energy. Complainant indicated that there was no adverse effect to the patient and no information on the effects to the rescuer due to the reported malfunction.
 
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Brand NameG3 PLUS, AED, AHA 2010, ENGLISH
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
CARDIAC SCIENCE CORPORATION
500 burdick parkway
deerfield WI 53531 9692
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key12499110
MDR Text Key272269085
Report Number2112020-2021-00904
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number9390E-1001
Device Catalogue Number9390E-1001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2017
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: 09/20/2021 Patient Sequence Number: 1
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