TRI-ANIM AIR OXYGEN BLENDER SMALL FOTA1000

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 2019-10-22 for TRI-ANIM AIR OXYGEN BLENDER SMALL FOTA1000 manufactured by Precision Medical, Inc..

MAUDE Entry Details

Report Number3007409280-2019-00045
MDR Report Key9219344
Report SourceCONSUMER,HEALTH PROFESSIONAL
Date Received2019-10-22
Date of Report2019-09-25
Date of Event2019-09-23
Date Mfgr Received2019-09-25
Date Added to Maude2019-10-22
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 Phone8004495328
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 NameTRI-ANIM AIR OXYGEN BLENDER SMALL
Generic NamePRECISION MEDICAL OXYGEN REGULATOR
Product CodeCAN
Date Received2019-10-22
Returned To Mfg2019-10-04
Model NumberFOTA1000
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPRECISION MEDICAL, INC.
Manufacturer Address300 HELD DR. NORTHAMPTON PA 18067 US 18067


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-22

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