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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G3 AED AED (AUTOMATED EXTERNAL DEFIBRILLATOR)

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CARDIAC SCIENCE CORPORATION POWERHEART G3 AED AED (AUTOMATED EXTERNAL DEFIBRILLATOR) Back to Search Results
Model Number 9300E
Device Problems Failure to Deliver Shock/Stimulation (1133); Intermittent Loss of Power (4016)
Patient Problems Cardiopulmonary Arrest (1765); Loss of consciousness (2418); Loss Of Pulse (2562)
Event Date 03/06/2019
Event Type  malfunction  
Manufacturer Narrative
The aed has been received and an investigation is underway.
 
Event Description
When the event was initially reported to cardiac science, the reporter stated that during a rescue the aed advised a shock and then shut down. The customer was asked to provide more details about the event and the information provided included the following: we were dispatched for an unconscious male with unknown breathing status. Upon arrival we found the rather large patient lying on the floor next to his bed with agonal breathing. His wife stated she thought he was sleeping; unknown how long until she called 911. We checked for a pulse but could not find one. We used a stethoscope to listen to the chest but could not hear a heartbeat. We started cpr. The patient had a stoma but did not have his breathing tube in it, which made it difficult to get a good seal with a bvm which was hooked up to oxygen. We opened the aed and it told us to attach the pads to the patient's chest. Then it said: "do not touch the patient, analyzing. " we stopped cpr for the analysis. After a few seconds the aed shut off and the screen showed "replace battery". We closed and reopened the lid a couple of times then the aed stated to "check electrodes" then "analyzing patient". And then" no shock advised, start cpr," which we did. Not at any point did it tell us to shock the patient. We continued cpr for two minutes and then the aed prompted "analyzing patient" again the aed stated no shock advised, and to start cpr, which we did for another two minutes. At this time the transporting ambulance arrived and their paramedic told us to remove our pads and he applied the pads from his heart monitor. He analyzed the rhythm and checked for a pulse. He also found the patient's breathing tube and inserted it in the patient's stoma. We continued to give breathes through the bvm while we loaded the patient onto a backboard to move him to the stretcher. The patient was loaded into the ambulance and the ambulance crew administered patient care to the hospital. Patient outcome is unknown.
 
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Brand NamePOWERHEART G3 AED
Type of DeviceAED (AUTOMATED 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 Key8489800
MDR Text Key141184659
Report Number2112020-2019-00008
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
Report Date 04/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number9300E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/13/2010
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: 04/06/2019 Patient Sequence Number: 1
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