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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 Problems High impedance (1291); Unable to Obtain Readings (1516)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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 without duplicating the report.Internal inspection of the device found no discrepancies.The error log was cleared.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
 
Event Description
Complainant alleged that during biomed testing, the device did not detect the attached electrode pads and failed for high impedance.Complainant indicated that there was no patient involvement in the reported malfunction.
 
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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
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key12438278
MDR Text Key271660857
Report Number2112020-2021-00813
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other
Type of Report Initial
Report Date 08/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2021
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 Manufacturer07/30/2021
Was the Report Sent to FDA? No
Date Manufacturer Received08/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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