MIXER, BREATHING GASES, ANESTHESIA INHALATION MICROBLENDER 03800A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-10-24 for MIXER, BREATHING GASES, ANESTHESIA INHALATION MICROBLENDER 03800A manufactured by Vyaire Medical.

Event Text Entries

[124964014] (b)(4). At this time, vyaire has not received the suspect device/component for evaluation.
Patient Sequence No: 1, Text Type: N, H10


[124964015] The customer reported that while using the micro blender, the fio2 was out of specification. The customer stated there was no patient involvement associated with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2021710-2018-09465
MDR Report Key8002318
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-10-24
Date of Report2018-09-27
Date of Event2018-09-27
Date Mfgr Received2018-09-27
Device Manufacturer Date2004-11-12
Date Added to Maude2018-10-24
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 ContactMINDY FABER
Manufacturer Street26125 NORTH RIVERWOODS BLVD
Manufacturer CityMETTAWA IL 60045
Manufacturer CountryUS
Manufacturer Postal60045
Manufacturer Phone8727570116
Manufacturer G1VYAIRE MEDICAL INC.
Manufacturer Street1100 BIRD CENTER DRIVE
Manufacturer CityPALM SPRINGS CA 92262
Manufacturer CountryUS
Manufacturer Postal Code92262
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMIXER, BREATHING GASES, ANESTHESIA INHALATION
Generic NameBIRD SENTRY AIR/OXYGEN MICROBLENDER
Product CodeBZR
Date Received2018-10-24
Model NumberMICROBLENDER
Catalog Number03800A
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerVYAIRE MEDICAL
Manufacturer Address26125 NORTH RIVERWOODS BLVD METTAWA IL 60045 US 60045


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-24

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