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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL, INC INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION; VENTILATOR, CONTINUOUS, FACILITY USE
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VYAIRE MEDICAL, INC INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number SIPAP
Device Problem No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Date 12/08/2017
Event Type  malfunction  
Manufacturer Narrative
(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 Description
It was reported to vyaire that the infant flow sipap experienced a blank screen prior to patient placement.The customer confirmed that there was no patient involvement associated with the reported issue.
 
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Brand Name
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
VYAIRE MEDICAL, INC
22745 savi ranch parkway
yorba linda CA 92887
Manufacturer (Section G)
VYAIRE MEDICAL INC.
1100 bird center dr.
palm springs CA 92262
Manufacturer Contact
mindy faber
26125 north riverwoods blvd
mettawa, IL 60045
8727570116
MDR Report Key7679619
MDR Text Key113748499
Report Number2021710-2018-09053
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K031745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSIPAP
Device Catalogue Number675-CFG-005
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/13/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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