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	11/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vyaire complaint number: (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 that the sipap failed while connected to a patient.The suspect device alarmed error 33 and was unable to auto zero.The clinician immediately removed the patient from the device.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Vyaire has determined that the initial report has been determined to be a duplicate submission.Please reference medwatch # (b)(4) for the correct manufacturer submission.

• 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: 8258445
• Report Number: 2021710-2019-09790
• Device Sequence Number: 13979581
• Product Code: CBK
• UDI-Device Identifier: 50846446004616
• UDI-Public: (01)50846446004616(11)BJP01853
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/03/2018

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: 27420-001
• Device Lot Number: BJP01853
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1