• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9192803
MDR Text Key186743073
Report Number2112020-2019-00020
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 health professional
Reporter Occupation
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
Device Model NumberG5A-80P1
Device Catalogue NumberG5A-80P1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/27/2018
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: 10/15/2019 Patient Sequence Number: 1
-
-