MAUDE Adverse Event Report: VYAIRE MEDICAL INFANT FLOW LP HEADGEAR, EXTRA SMALL; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	INFANT FLOW LP HEADGEAR, EXTRA SMALL
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	10/03/2019
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, since the investigation is still ongoing.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 patient was discovered to have a purplish spot on the forehead after using the infant flow lp headgear the entire night.The wound was sutured and applied ointment, and the baby was put on oxygen cannulae.However, the customer and end user both agreed that this is a case of device misuse as 3-hour checks of the device had not been done as indicated by the manufacturer and by the department protocol.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation and the device history record could not be obtained using the lot number 62396459.Therefore, no root cause has been determined.

• Brand Name: INFANT FLOW LP HEADGEAR, EXTRA SMALL
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9919200
• Report Number: 8030673-2020-00094
• Device Sequence Number: 3355210
• Product Code: CBK
• UDI-Device Identifier: 20846446004493
• UDI-Public: (01)20846446004493(10)00062396459
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2020

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 LP HEADGEAR, EXTRA SMALL
• Device Catalogue Number: 777040XS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 08/03/2020
• 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
• Patient Age: 15 DA