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	Low Oxygen Saturation (2477)
Date of Event	01/02/2019
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.Results of investigation: a vyaire failure analysis technician was unable to verify the customer's reported issue.The ventilator passed all testing and met all vyaire manufacturer specifications.
Event or Problem Description
It was reported to vyaire that the sipap unit stopped delivering oxygen while transporting a patient.The patient was immediately removed from the device and provided positive pressure ventilation via manual resuscitator.The customer stated that patient harm is unknown at this time.The baby suffered from unknown acidosis and tried to compensate it by increasing respiration.This was the reason to transport the baby to the university hospital.At this point, there is no indications about brain damage.

• 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: 8436518
• Report Number: 2021710-2019-10020
• Device Sequence Number: 19345858
• Product Code: CBK
• UDI-Device Identifier: 10846446005387
• UDI-Public: (01)10846446005387(11)20120326
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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
• Report Date (Section B): 02/22/2019

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-004
• Device Lot Number: BCN01314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention