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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-80P1
Device Problems Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Cardiac Arrest (1762)
Event Date 09/16/2019
Event Type  malfunction  
Manufacturer Narrative
The nurse was asked to send the aed to cardiac science for investigation.
 
Event Description
School nurse was called to the classroom for a student who had passed out and upon arrival found the student being support by a teacher.Nurse assisted moving the student to the floor.Student was unresponsive but breathing.Nurse was unable to palpate a pulse and the student was cold, clammy, and pale.Another teacher was sent for the aed and 911 was called.Aed pads were placed on the student and the aed analyzed the patient's rhythm, advised a shock, and a shock was delivered.Student became responsive after the shock, bp was normal, and hr was between 120 - 140.Ems arrived, assumed care, and transported the student to children's hospital er.Aed event log was downloaded and sent to a cardiologist at the hospital per request.The cardiologist notified the school rn that the student was in normal sinus rhythm during the event and a shock should not have been delivered.The patient survived.
 
Event Description
School nurse was called to the classroom for a student who had passed out and upon arrival found the student being support by a teacher.Nurse assisted moving the student to the floor.Student was unresponsive but breathing.Nurse was unable to palpate a pulse and the student was cold, clammy, and pale.Another teacher was sent for the aed and 911 was called.Aed pads were placed on the student and the aed analyzed the patient's rhythm, advised a shock, and a shock was delivered.Student became responsive after the shock, bp was normal, and hr was between 120 - 140.Ems arrived, assumed care, and transported the student to children's hospital er.Aed event log was downloaded and sent to a cardiologist at the hospital per request.The cardiologist notified the school rn that the student was in normal sinus rhythm during the event and a shock should not have been delivered.The patient survived.
 
Manufacturer Narrative
The customer's aed was received at cardiac science and the rescue data file was downloaded.Review of the data, which included cardiac science's medical director, concluded a shock had been delivered to a non-shockable rhythm.The patient's organized rhythm was determined to be shockable because the aed detected tall t waves and some p waves as peaks which resulted in a detected heart rate above the detection threshold.The aed correctly synchronized the shock and caused no proarrhythmic changes.Based upon information provided by the customer, the patient was unconscious when the shock was delivered.As part of the investigation, the aed was functionally evaluated and successfully passed testing to factory specifications.The aed will be serviced and returned to the customer.
 
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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 Key9192803
MDR Text Key186743073
Report Number2112020-2019-00020
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00812394021222
UDI-Public00812394021222
Combination Product (y/n)N
PMA/PMN Number
P160033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG5A-80P1
Device Catalogue NumberG5A-80P1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2019
Date Manufacturer Received09/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening;
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