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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION ST JOHN AMB G5 AED, AUTO, ICPR PADS AUTOMATED EXTERNAL DEFIBRILLATOR

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CARDIAC SCIENCE CORPORATION ST JOHN AMB G5 AED, AUTO, ICPR PADS AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number G5A-31C-SJA
Device Problem Failure of Device to Self-Test (2937)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to zoll medical corporation. The customer's report was verified and attributed to corrupted language file. The firmware was reloaded to remedy the report. 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 functional testing, the device prompted a "unit failed" message. Complainant did not indicate that there was any patient involvement in the reported malfunction.
 
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Brand NameST JOHN AMB G5 AED, AUTO, ICPR PADS
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 Key12524971
MDR Text Key273993358
Report Number2112020-2021-00946
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberG5A-31C-SJA
Device Catalogue NumberG5A-31C-SJA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2021
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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