LIFEVEST WCD 4000 SYSTEM 10A0988

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-29 for LIFEVEST WCD 4000 SYSTEM 10A0988 manufactured by Zoll Manufacturing Corporation.

MAUDE Entry Details

Report Number3008642652-2020-02685
MDR Report Key9896090
Report SourceDISTRIBUTOR
Date Received2020-03-29
Date of Report2020-03-28
Date of Event2020-02-24
Date Mfgr Received2020-02-28
Device Manufacturer Date2018-07-17
Date Added to Maude2020-03-29
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 ContactELIZA SCHALLY
Manufacturer Street121 GAMMA DRIVE
Manufacturer CityPITTSBURGH, PA
Manufacturer CountryUS
Manufacturer Phone9683333
Manufacturer G1ZOLL MANUFACTURING CORPORATION
Manufacturer Street121 GAMMA DRIVE
Manufacturer CityPITTSBURGH, PA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIFEVEST WCD 4000 SYSTEM
Generic NameWEARABLE CARDIOVERTER DEFIBRILLATOR
Product CodeMVK
Date Received2020-03-29
Model NumberWCD 4000
Catalog Number10A0988
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZOLL MANUFACTURING CORPORATION
Manufacturer Address121 GAMMA DRIVE PITTSBURGH, PA US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 2020-03-29

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