MAUDE Adverse Event Report: VYAIRE MEDICAL INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION; VENTILATOR, CONTINUOUS, FACILITY USE

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	08/03/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported to vyaire medical that the sipap device experienced loss of pressure while connected to a patient.The device also alarmed error codes 33 and 42.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Results of investigation: a vyaire failure analysis lab technician was unable to verify the customer's reported issue.The device passed all testing and met all vyaire manufacturer specifications.

• 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 Key: 8957903
• Report Number: 2021710-2019-10748
• Device Sequence Number: 16774491
• Product Code: CBK
• UDI-Device Identifier: 10846446005387
• UDI-Public: (01)10846446005387(11)20181227
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K031745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2019

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 Number: INFANT FLOW SIPAP
• Device Catalogue Number: 27444-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2019
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other