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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, NON-CONTINUOUS
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VYAIRE MEDICAL INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION; VENTILATOR, NON-CONTINUOUS Back to Search Results
Model Number SIPAP
Device Problem Computer Software Problem (1112)
Patient Problem No Patient Involvement (2645)
Event Date 01/25/2019
Event Type  malfunction  
Manufacturer Narrative
Vyaire medical complaint number: : (b)(4).Vyaire medical has not received the suspect device, once received and evaluated, a follow-up medwatch report will be submitted.
 
Event Description
It was reported to vyaire medical that the sipap unit displays an e90 error and requires rebooting when connected to the hospital information system.There was no patient involvement associated with this reported event.
 
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Brand Name
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
Type of Device
VENTILATOR, NON-CONTINUOUS
Manufacturer (Section D)
VYAIRE MEDICAL
22745 savi ranch pkwy
yorba linda CA 92887
Manufacturer (Section G)
VYAIRE MEDICAL INC.
1100 bird center drive
palm springs CA 92262
Manufacturer Contact
stanley tan
22745 savi ranch pkwy
yorba linda, CA 92887
7149193324
MDR Report Key8700225
MDR Text Key148032384
Report Number2021710-2019-10380
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K031745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSIPAP
Device Catalogue Number27428-001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/30/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/17/2018
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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