Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT,AUTO,US EN/FRN CA, CPR; AUTOMATED EXTERNAL DEFIBRILLATOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT,AUTO,US EN/FRN CA, CPR; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number G5A-90C
Device Problem Failure to Charge (1085)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to zoll medical corporation; the customer's report was duplicated and attributed to a faulty integrated circuit on the main board.The main board was replaced to resolve the report.The device was recertified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
 
Event Description
Complainant alleged that during functional testing, the device prompted an "hv cap idle test failure" message.Complainant did not indicate that there was any patient involvement in the reported malfunction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
POWERHEART G5 KIT,AUTO,US EN/FRN CA, CPR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
CARDIAC SCIENCE CORPORATION
500 burdick parkway
deerfield MA 53531 9692
Manufacturer Contact
scott august
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key19201349
MDR Text Key341286991
Report Number2112020-2024-00331
Device Sequence Number1
Product Code MKJ
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
Report Date 04/15/2024
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
Device Operator Other
Device Model NumberG5A-90C
Device Catalogue NumberG5A-90C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/15/2024
Initial Date FDA Received04/29/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-