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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION; VENTILATOR, CONTINUOUS, FACILITY USE
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VYAIRE MEDICAL INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number INFANT FLOW SIPAP
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/17/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Vyaire complaint number: (b)(4).Any additional information provided by the customer will be included in a follow up report.At this time, vyaire has not received the suspect device/component for evaluation.
 
Event or Problem Description
It was reported to vyaire that the sipap unit shut down while connected to a patient.The customer confirmed that there was no patient harm associated with the reported event.
 
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Brand Name
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
VYAIRE MEDICAL
22745 savi ranch pkwy
yorba linda CA 92887
MDR Report Key8298941
Report Number2021710-2019-09836
Device Sequence Number14128596
Product Code CBK
UDI-Device Identifier10846446005387
UDI-Public(01)10846446005387
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K031745
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberINFANT FLOW SIPAP
Device Catalogue Number27428-001
Device Lot NumberBJP01223
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/04/2019
Initial Report FDA Received Date02/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
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