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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT, AUTO, US ENGLISH; AUTOMATED EXTERNAL DEFIBRILLATOR
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CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT, AUTO, US ENGLISH; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number G5A-01A
Medical Device Problem Code Battery Problem (2885)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.The customer's report was observed during review of the device data logs.However, the device was put through extensive testing including full functionality testing and stress testing without duplicating the report.The report was cleared and did not reoccur.An internal inspection of the device found no discrepancies.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
 
Event or Problem Description
Complainant alleged that during incoming testing, the device displayed a "battery high voltage" message.Complainant indicated that there was no patient involvement in the reported malfunction.
 
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Brand Name
POWERHEART G5 KIT, AUTO, US ENGLISH
Common Device Name
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
CARDIAC SCIENCE CORPORATION
500 burdick parkway
deerfield WI 53531 9692
MDR Report Key10870461
Report Number2112020-2020-01007
Device Sequence Number3228546
Product Code MKJ
UDI-Device Identifier00812394021185
UDI-Public00812394021185
Combination Product (Y/N)N
Initial Reporter StateAR
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Model NumberG5A-01A
Device Catalogue NumberG5A-01A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2020
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/12/2020
Initial Report FDA Received Date11/19/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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