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

Model Number	INFANT FLOW SIPAP
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire technical support informed the customer to calibrate the device first and if issue continues he needs to replace the 02 sensor.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported he was having issue with the oxygen on the sipap ventilator.The customer reported there was no patient involvement associated with the reported event.

• Brand Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12200129
• Report Number: 2021710-2021-14153
• Device Sequence Number: 11660299
• Product Code: CBK
• UDI-Device Identifier: 10846446004847
• UDI-Public: (01)10846446004847(11)20070510
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K031745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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: INFANT FLOW SIPAP
• Device Catalogue Number: 675-CFG-005
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1