R SERIES DEFIBRILLATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-11-04 for R SERIES DEFIBRILLATOR manufactured by Zoll Medical Corporation.

MAUDE Entry Details

Report Number1220908-2019-03346
MDR Report Key9273652
Report SourceFOREIGN
Date Received2019-11-04
Date of Report2019-10-14
Date Mfgr Received2019-10-14
Device Manufacturer Date2017-09-01
Date Added to Maude2019-11-04
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 NameR SERIES DEFIBRILLATOR
Generic NameDEFIBRILLATOR/PACEMAKER
Product CodeDRO
Date Received2019-11-04
Model NumberR SERIES
Catalog NumberR SERIES
Lot NumberNA
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZOLL MEDICAL CORPORATION
Manufacturer Address269 MILL ROAD CHELMSFORD MA 01824 US 01824


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-04

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