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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT, AUTO, US EN/LA ESP AUTOMATED EXTERNAL DEFIBRILLATOR

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CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT, AUTO, US EN/LA ESP AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number G5A-80A
Device Problem Mechanics Altered (2984)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that during functional testing, the device powered on in manual mode. Complainant did not indicate that there was any patient involvement in the reported malfunction.
 
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Brand NamePOWERHEART G5 KIT, AUTO, US EN/LA ESP
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
CARDIAC SCIENCE CORPORATION
500 burdick parkway
deerfield WI 53531 9692
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key11236649
MDR Text Key229589269
Report Number2112020-2021-00030
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberG5A-80A
Device Catalogue NumberG5A-80A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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