OASIS BRU W/AC 3650-100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-03 for OASIS BRU W/AC 3650-100 manufactured by Atrium Medical Corporation.

MAUDE Entry Details

Report Number3011175548-2019-00739
MDR Report Key8761478
Date Received2019-07-03
Date of Report2019-07-09
Date of Event2019-06-14
Date Mfgr Received2019-07-08
Date Added to Maude2019-07-03
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 Street40 CONTINENTAL BLVD
Manufacturer CityMERRIMACK NH 03054
Manufacturer CountryUS
Manufacturer Postal03054
Manufacturer G1ATRIUM MEDICAL CORPORATION
Manufacturer Street40 CONTINENTAL BLVD
Manufacturer CityMERRIMACK NH 03054
Manufacturer CountryUS
Manufacturer Postal Code03054
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameOASIS BRU W/AC
Generic NameAPPARATUS, AUTOTRANSFUSION
Product CodeCAC
Date Received2019-07-03
Model Number3650-100
Catalog Number3650-100
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerATRIUM MEDICAL CORPORATION
Manufacturer Address40 CONTINENTAL BLVD MERRIMACK NH 03054 US 03054


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-03

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