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

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 2020-02-13 for INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION INFANT FLOW SIPAP 27444-001 manufactured by Vyaire Medical..

Event Text Entries

[187720134] (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 determine yet.
Patient Sequence No: 1, Text Type: N, H10


[187720135] The customer reported that the sipap ventilator's touch screen is not working due to water damage. It was also reported that the bottom right hand corner of the screen had been delaminated. There is no patient involvement in this reported event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2021710-2020-11359
MDR Report Key9709196
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-02-13
Date of Report2020-01-17
Date of Event2020-01-06
Date Mfgr Received2020-01-17
Device Manufacturer Date2016-11-30
Date Added to Maude2020-02-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMINDY FABER
Manufacturer Street26125 N. 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 NameINFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
Generic NameVENTILATOR, NON-CONTINUOUS
Product CodeBZD
Date Received2020-02-13
Model NumberINFANT FLOW SIPAP
Catalog Number27444-001
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerVYAIRE MEDICAL.
Manufacturer Address26125 N. RIVERWOODS BLVD. METTAWA IL 60045 US 60045


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-13

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