INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION 27444-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-01-10 for INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION 27444-001 manufactured by Vyaire Medical.

Event Text Entries

[181174820] (b)(4). At this time, vyaire medical has not receive the device for evaluation. Once received and evaluated, a follow-up medwatch report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[181174821] It was reported to vyaire medical that the unit had no pressure while in cpap mode. There was no report of any patient involvement associated with this reported event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2021710-2020-11250
MDR Report Key9576169
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-01-10
Date of Report2020-01-10
Date of Event2019-12-05
Date Mfgr Received2019-12-12
Device Manufacturer Date2016-02-29
Date Added to Maude2020-01-10
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 ContactMR. STANLEY 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 NameINFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
Generic NameVENTILATOR, NON-CONTINUOUS
Product CodeBZD
Date Received2020-01-10
Model NumberSIPAP
Catalog Number27444-001
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerVYAIRE MEDICAL
Manufacturer Address22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-10

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