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

Model Number	SIPAP
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).At this time, vyaire medical has not received the suspect device.Once received and evaluated, a follow-up medwatch report will be submitted.
Event or Problem Description
It was reported that the "internal pressure drop".There was no report of any patient involvement associated with this reported event.
Additional Manufacturer Narrative
This unit was field serviced by a vyaire medical authorized service technician.The service technician was able to verify the customer's reported issue during testing and evaluation.The reported issue was due to a blockage at the left flow meter.The service technician realigned the flow meter block to resolve the reported issue.

• Brand Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
• Common Device Name: VENTILATOR, NON-CONTINUOUS
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8487637
• Report Number: 2021710-2019-10087
• Device Sequence Number: 19429208
• Product Code: BZD
• UDI-Device Identifier: 10846446005387
• UDI-Public: (01)10846446005387(11)20150522
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SIPAP
• Device Catalogue Number: 27476-001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1