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U.S. Department of Health and Human Services

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

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CARDIAC SCIENCE CORPORATION POWERHEART AED G5 AUTOMATIC AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number G5A-80A
Device Problem Battery Problem (2885)
Patient Problem Loss of consciousness (2418)
Event Date 09/19/2016
Event Type  malfunction  
Manufacturer Narrative
The aed and battery were received at csc and evaluated. Aed failed incoming tests due to a depleted battery and lid closed off-current measuring out of tolerance. Evaluation of the main pcba found no faulty components and testing found the problem to be intermittent. The aed was placed in an environmental chamber and the off-current was monitored. The reading at the beginning of the test was normal, but increased over time. The probable root cause of the intermittent high off-current was determined to be a poor or cold solder joint on the main pcba. The customer received a replacement aed.
 
Event Description
Rn was called regarding an unresponsive student. The student was moved to the floor and assessed. The aed arrived at the scene and was applied to the student as a precautionary measure. The aed had a green light indicating it was ready for use. The aed prompted the user to apply pads and after placing pads on the patient the aed stopped working. Patient outcome was good and the student returned to school. The cause of the patient's problem wasn't identified.
 
Manufacturer Narrative
Investigation is in process.
 
Event Description
Rn was called regarding an unresponsive student. The student was moved to the floor and assessed. The aed arrived at the scene and was applied to the student as a precautionary measure. The aed had a green light indicating it was ready for use. The aed prompted the user to apply pads and after placing pads on the patient the aed stopped working. Patient outcome was good and the student returned to school. The cause of the patient's problem wasn't identified.
 
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Brand NamePOWERHEART AED G5 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 Key6060237
MDR Text Key113937778
Report Number2112020-2016-00010
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143714
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG5A-80A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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