G3 PLUS AUTO, AED,GERMAN, PKG 9390A-508

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-31 for G3 PLUS AUTO, AED,GERMAN, PKG 9390A-508 manufactured by Cardiac Science Corporation.

Event Text Entries

[188526071] Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Patient Sequence No: 1, Text Type: N, H10


[188526072] Complainant alleged that while attempting to defibrillate a female patient (age unknown), the device self discharged. Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2112020-2020-00236
MDR Report Key9908271
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-03-31
Date of Report2020-02-28
Date of Event2020-02-14
Date Mfgr Received2020-02-28
Device Manufacturer Date2009-03-31
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street269 MILL ROAD
Manufacturer CityCHELMSFORD MA 01824
Manufacturer CountryUS
Manufacturer Postal01824
Manufacturer Phone9784219552
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameG3 PLUS AUTO, AED,GERMAN, PKG
Generic NameAUTOMATED EXTERNAL DEFIBRILLATOR
Product CodeMKJ
Date Received2020-03-31
Model Number9390A-508
Catalog Number9390A-508
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCARDIAC SCIENCE CORPORATION
Manufacturer Address500 BURDICK PARKWAY DEERFIELD WI 535319692 US 535319692


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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