P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER 10011A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-12-20 for P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER 10011A manufactured by Vyaire Medical.

Event Text Entries

[131045620] (b)(4). Any additional information received from the customer will be included in a follow-up report. At this time, the suspect device has not been received for evaluation.
Patient Sequence No: 1, Text Type: N, H10


[131045621] The customer reported while using the low flow microblender; the loss of oxygen/air high pressure alarm fails. The customer performed troubleshooting, but the issue went unresolved. The customer reported there is no patient involvement associated with the event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2021710-2018-09691
MDR Report Key8185186
Report SourceDISTRIBUTOR,FOREIGN
Date Received2018-12-20
Date of Report2018-11-21
Date of Event2018-11-21
Date Mfgr Received2018-11-21
Device Manufacturer Date2013-07-01
Date Added to Maude2018-12-20
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 ContactSTANLEY TAN
Manufacturer Street22745 SAVI RANCH PKWY
Manufacturer CityYORBA LINDA CA 92887
Manufacturer CountryUS
Manufacturer Postal92887
Manufacturer Phone7149193324
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 NameP/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
Generic NameMIXER, BREATHING GASES, ANESTHESIA INHALATION
Product CodeBZR
Date Received2018-12-20
Model NumberBLENDER
Catalog Number10011A
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerVYAIRE MEDICAL
Manufacturer Address22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-20

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