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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: 81 other - the suspect device/part was not returned for evaluation.Therefore, no root cause could be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.H3 other text : device was not returned.
Event or Problem Description
It was reported to vyaire medical that the sipap ventilator shut down on patient.It was also stated that an e50 and an e40 alarm has occurred on the unit.Furthermore, the patient was transferred to another device and there was no patient harm associated with the event.

• Brand Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 7607787281
• MDR Report Key: 16834971
• Report Number: 2021710-2023-17586
• Device Sequence Number: 7536867
• Product Code: CBK
• UDI-Device Identifier: 10846446004847
• UDI-Public: (01)10846446004847(11)20070725
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2023

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: 675-CFG-005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown