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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; VENTILATOR, CONTINUOUS, FACILITY USE
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VYAIRE MEDICAL INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number INFANT FLOW SIPAP
Device Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2021
Event Type  malfunction  
Manufacturer Narrative
Vyaire medical file identification: pc-(b)(4).The suspect device / component has not been returned to vyaire.Therefore, a definitive root cause cannot be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
Event Description
It is reported to vyaire medical that the sipap ventilator experienced no audible alarm.The customer confirmed there was no patient involvement associated with the reported issue.
 
Manufacturer Narrative
Vyaire complaint: (b)(4).Result of investigation: vyaire medical's failure analysis team was able to duplicate the customer reported problem of low alarm at start up, due to a bad main board.The main board was replaced and testing was performed.
 
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Brand Name
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa IL 60045
MDR Report Key11556011
MDR Text Key241848290
Report Number2021710-2021-13587
Device Sequence Number1
Product Code CBK
UDI-Device Identifier10846446004847
UDI-Public(01)10846446004847(11)20120803
Combination Product (y/n)N
PMA/PMN Number
K031745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberINFANT FLOW SIPAP
Device Catalogue Number675-CFG-005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2021
Date Manufacturer Received03/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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