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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT,SEMI,US EN/FRN CA, CPR; AUTOMATED EXTERNAL DEFIBRILLATOR

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CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT,SEMI,US EN/FRN CA, CPR; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number G5S-90C
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 prompted an "hv dump failure" message.Complainant did not indicate that there was any patient involvement in the reported 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 including functionality testing without duplicating the report.The main board was replaced as a precaution.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,US EN/FRN CA, CPR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
CARDIAC SCIENCE CORPORATION
500 burdick parkway
deerfield WI 53531 9692
Manufacturer Contact
scott august
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key16713497
MDR Text Key313038321
Report Number2112020-2023-00265
Device Sequence Number1
Product Code MJK
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P160033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberG5S-90C
Device Catalogue NumberG5S-90C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2023
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2020
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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