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

Model Number	INFANT FLOW SIPAP
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report at this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determined yet.
Event or Problem Description
It was reported to vyaire medical that a premature infant suffered from severe injuries to the face while connected to the sipap unit.The customer stated that the issue was potentially caused by improper placement of the face mask or the use of disinfectants.The customer confirmed that there are no allegations against the sipap device.

• Brand Name: INFANT FLOW SIPAP
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12243027
• Report Number: 2021710-2021-14301
• Device Sequence Number: 5097303
• Product Code: CBK
• UDI-Device Identifier: 10190752164895
• UDI-Public: (01)10190752164895
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• 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: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2021

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: 27476-001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 DA