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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL INFANT FLOW SIPAP; VENTILATOR, NON-CONTINUOUS
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VYAIRE MEDICAL INFANT FLOW SIPAP; VENTILATOR, NON-CONTINUOUS Back to Search Results
Model Number 27444-001
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/08/2019
Event Type  Injury  
Manufacturer Narrative
The suspect component has been returned to vyaire's failure analysis laboratory for evaluation.At this time, the evaluation is still pending.Once the evaluation is complete, a supplemental report will be submitted.
 
Event Description
The customer reported an error e33, while in patient use on this non-invasive ventilator device.The customer stated no patient harm or injury was associated with this event.
 
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Brand Name
INFANT FLOW SIPAP
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 Key9450723
MDR Text Key170247960
Report Number2021710-2019-11125
Device Sequence Number1
Product Code BZD
UDI-Device Identifier10846446063554
UDI-Public(01)10846446063554(11)20181114
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K031745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/14/2019
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
Device Operator Health Professional
Device Model Number27444-001
Device Catalogue Number27444-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/14/2019
Initial Date FDA Received12/11/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/14/2018
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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