BIRD HIGH FLOW BLENDER SERIES 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 2018-06-14 for BIRD HIGH FLOW BLENDER SERIES 03800A manufactured by Vyaire Medical, Inc.

Event Text Entries

[111096302] Vyaire file identification: (b)(4). Any additional information received from the customer will be included in a follow-up report. The suspect device was returned to vyaire's factory service for evaluation. An investigation was performed and was unable to be confirmed as fio2 was in specifications. The o2/air inlet alarm was able to be confirmed as the most likely cause of the issue was due to a faulty alarm cap. The device was repaired and returned to service specifications.
Patient Sequence No: 1, Text Type: N, H10


[111096303] The customer reported while using the bird high flow blender series; the fraction of inspired oxygen (fio2) is off by twenty percent. The customer reported the o2/air inlet alarms are not working when one of the gases is disconnected. The customer reported there is no patient involvement associated with the event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2021710-2018-07949
MDR Report Key7601989
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-06-14
Date of Report2018-06-14
Date of Event2018-05-16
Date Mfgr Received2018-05-16
Device Manufacturer Date2013-12-01
Date Added to Maude2018-06-14
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 ContactAVERY FOSTER
Manufacturer Street22745 SAVI RANCH PARKWAY
Manufacturer CityYORBA LINDA CA 92887
Manufacturer CountryUS
Manufacturer Postal92887
Manufacturer G1VYAIRE MEDICAL, INC
Manufacturer Street1100 BIRD CENTER DR.
Manufacturer CityPALM SPRINGS CA 92262
Manufacturer CountryUS
Manufacturer Postal Code92262
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIRD HIGH FLOW BLENDER SERIES
Generic NameMIXER, BREATHING GASES, ANESTHESIA INHALATION
Product CodeBZR
Date Received2018-06-14
Returned To Mfg2018-06-08
Model NumberBLENDER
Catalog Number03800A
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerVYAIRE MEDICAL, INC
Manufacturer Address22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-14

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