INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION INFANT FLOW SIPAP 675-CFG-012

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-24 for INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION INFANT FLOW SIPAP 675-CFG-012 manufactured by Vyaire Medical..

Event Text Entries

[184318001] (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 returned for evaluation. Therefore, no root cause could be determined yet.
Patient Sequence No: 1, Text Type: N, H10


[184318002] The customer reported to vyaire that the sipap device shows a failure (read manual message symbol) without error code, no alarm and it cannot build up pressure. There is no patient involvement associated with the event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2021710-2020-11429
MDR Report Key9747699
Report SourceFOREIGN,USER FACILITY
Date Received2020-02-24
Date of Report2020-01-28
Date of Event2020-01-28
Date Mfgr Received2020-01-28
Device Manufacturer Date2012-09-28
Date Added to Maude2020-02-24
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 N. RIVERWOODS BLVD.
Manufacturer CityMETTAWA, IL
Manufacturer CountryUS
Manufacturer Phone7570116
Manufacturer G1VYAIRE MEDICAL INC.
Manufacturer Street1100 BIRD CENTER DRIVE
Manufacturer CityPALM SPRINGS, CA
Manufacturer CountryUS
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 (RESPIRATOR)
Product CodeBZD
Date Received2020-02-24
Model NumberINFANT FLOW SIPAP
Catalog Number675-CFG-012
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerVYAIRE MEDICAL.
Manufacturer Address26125 N. RIVERWOODS BLVD. METTAWA, IL US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-24

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