ACROBAT-I STABILIZER OM-10000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-10-31 for ACROBAT-I STABILIZER OM-10000 manufactured by Maquet Cardiovascular Llc.

MAUDE Entry Details

Report Number2242352-2019-01218
MDR Report Key9263663
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-10-31
Date of Report2019-10-31
Date of Event2019-10-09
Date Mfgr Received2019-10-09
Device Manufacturer Date2019-03-13
Date Added to Maude2019-10-31
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 Street45 BARBOUR POND DRIVE
Manufacturer CityWAYNE NJ 07470
Manufacturer CountryUS
Manufacturer Postal07470
Manufacturer G1MAQUET CARDIOVASCULAR LLC
Manufacturer Street45 BARBOUR POND DRIVE
Manufacturer CityWAYNE NJ 07470
Manufacturer CountryUS
Manufacturer Postal Code07470
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACROBAT-I STABILIZER
Generic NameSTABILIZER, HEART
Product CodeMWS
Date Received2019-10-31
Model NumberACROBAT-I STABILIZER
Catalog NumberOM-10000
Lot Number25145359
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMAQUET CARDIOVASCULAR LLC
Manufacturer Address45 BARBOUR POND DRIVE WAYNE NJ 07470 US 07470


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-31

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