BIO-MED DEVICES OXYGEN BLENDER FOBM1000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2019-10-23 for BIO-MED DEVICES OXYGEN BLENDER FOBM1000 manufactured by Biomedical Devices, Inc..

MAUDE Entry Details

Report Number3007409280-2019-00059
MDR Report Key9228130
Report SourceCONSUMER,HEALTH PROFESSIONAL
Date Received2019-10-23
Date of Report2018-11-27
Date of Event2018-11-27
Date Mfgr Received2018-11-27
Date Added to Maude2019-10-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJENNA VARGAS
Manufacturer Street212 AVENIDA FABRICANTE
Manufacturer CitySAN CLEMENTE CA 92672
Manufacturer CountryUS
Manufacturer Postal92672
Manufacturer G1AVANTE HEALTH SOLUTIONS
Manufacturer Street212 AVENIDA FABRICANTE
Manufacturer CitySAN CLEMENTE CA 92672
Manufacturer CountryUS
Manufacturer Postal Code92672
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIO-MED DEVICES OXYGEN BLENDER
Generic NameBMD AIR/OXYGEN BLENDER
Product CodeBZR
Date Received2019-10-23
Model NumberFOBM1000
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMEDICAL DEVICES, INC.
Manufacturer Address8 BISHOP LN. MADISON CT 06443 US 06443


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-23

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