S5 ROLLER PUMP 10-80-00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-06 for S5 ROLLER PUMP 10-80-00 manufactured by Livanova Deutschland.

MAUDE Entry Details

Report Number1718850-2019-01158
MDR Report Key9283667
Date Received2019-11-06
Date of Report2019-11-05
Date of Event2019-10-09
Date Facility Aware2019-10-09
Date Mfgr Received2019-10-09
Date Added to Maude2019-11-06
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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 CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameS5 ROLLER PUMP
Generic NameCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Product CodeDWB
Date Received2019-11-06
Model Number10-80-00
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Age2 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerLIVANOVA DEUTSCHLAND
Manufacturer AddressLINDBERGHSTR. 25 MUNICH 80309 GM 80309


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-06

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