S3 BUBBLE DETECTOR 23-07-50

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-11 for S3 BUBBLE DETECTOR 23-07-50 manufactured by Livanova Deutschland.

MAUDE Entry Details

Report Number9611109-2019-00809
MDR Report Key9178245
Report SourceHEALTH PROFESSIONAL
Date Received2019-10-11
Date of Report2019-10-10
Date of Event2018-01-18
Date Mfgr Received2018-01-18
Device Manufacturer Date2015-05-21
Date Added to Maude2019-10-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactENRICO GRECO
Manufacturer Street14401 W. 65TH WAY
Manufacturer CityARVADA CO 80004
Manufacturer CountryUS
Manufacturer Postal80004
Manufacturer G1LIVANOVA DEUTSCHLAND
Manufacturer StreetLINDBERGHSTR. 25
Manufacturer CityMUNICH 80309
Manufacturer CountryGM
Manufacturer Postal Code80309
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameS3 BUBBLE DETECTOR
Generic NameMONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS
Product CodeKRL
Date Received2019-10-11
Model Number23-07-50
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLIVANOVA DEUTSCHLAND
Manufacturer AddressLINDBERGHSTR. 25 MUNICH 80309 GM 80309


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-11

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