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 foreign,health professional report with the FDA on 2020-03-27 for LIFEVEST WCD 4000 SYSTEM 10A0988 manufactured by Zoll Manufacturing Corporation.

Event Text Entries

[186727987] Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces of the lifevest device as well as the blue(tm) defibrillation gel.
Patient Sequence No: 1, Text Type: N, H10


[186727988] A us distributor contacted zoll to report that a patient reported that the lifevest was cutting into his skin. Patient reported that his left and right sides are sore and that he has a cut on his back below the therapy electrodes. There was no alleged device malfunction contributing to the irritation. Patient reported that while in hospital, a physician placed something on the cut. There is no indication that the patient was in hospital due to irritation. The medical outcome of the rash is unknown as follow up attempts were unsuccessful.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008642652-2020-02581
MDR Report Key9889295
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-27
Date of Report2020-03-26
Date of Event2020-03-09
Date Mfgr Received2020-03-20
Date Added to Maude2020-03-27
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 ContactANNA BEATTY
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 Received2020-03-27
Model NumberWCD 4000
Catalog Number10A0988
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerZOLL MANUFACTURING CORPORATION
Manufacturer Address121 GAMMA DRIVE PITTSBURGH, PA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2020-03-27

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