MAUDE Adverse Event Report: VYAIRE MEDICAL INC. 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	06/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.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 that the sipap ventilator experienced went into demo mode while on patient.The display showed unit was in live demo mode but continued to function properly.As an intervention, they removed unit from patient.Re-set unit into normal mode and put the patient back.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Vyaire complaint number (b)(4).Results of investigation: vyaire received the sample for evaluation.The service technician was unable to duplicate the reported issue, but the issue was confirmed through the event logs.A root cause could not be determined.No functional issues were found during testing, thus no further actions were needed.Able to confirm the reported complaint through the events log and duplicated during functional check.The root cause was determined to be a solenoid failure.

• Brand Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 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 dr; irvine, IL 92618
• MDR Report Key: 12178141
• Report Number: 2021710-2021-14137
• Device Sequence Number: 19066370
• Product Code: CBK
• UDI-Device Identifier: 10846446004847
• UDI-Public: (01)10846446004847(11)20071217
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2007
• 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