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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT, SEMI, UK; AUTOMATED EXTERNAL DEFIBRILLATOR
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CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT, SEMI, UK; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number G5S-02A
Device Problem Unable to Obtain Readings (1516)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
 
Event Description
Complainant alleged that during functional testing, the device displayed an "ecg fault -501" error message.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The customer's report was observed during review of the device logs.However, the device was put through extensive testing without duplicating the report.An internal inspection resulted in no findings.The report was cleared.The device was recertified and returned to the customer.The electrode pads used were not returned as part of this investigation.Analysis of reports of this type has not identified an increase in trend.
 
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Brand Name
POWERHEART G5 KIT, SEMI, UK
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
CARDIAC SCIENCE CORPORATION
500 burdick parkway
deerfield WI 53531 9692
MDR Report Key12564321
MDR Text Key275179787
Report Number2112020-2021-00960
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberG5S-02A
Device Catalogue NumberG5S-02A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2021
Was the Report Sent to FDA? No
Date Manufacturer Received09/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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