MAUDE Adverse Event Report: VYAIRE MEDICAL PACKAGE ASSEMBLY,INFANT FLOW,LP; GENERATOR AND CIRCUITS

Model Number	PACKAGE ASSEMBLY,INFANT FLOW,LP
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Investigation is still ongoing.Therefore, no root cause could be determine yet.Any additional information received from the customer will be included in a follow-up report.
Event or Problem Description
The customer reported that the infant flow with a set of continuous positive nasal pressure generator had pressure anomaly (positive expiratory pressure and inspiratory pressure) while in use on a patient that resulted in decreased oxygen saturation (sao2) in the neonate.At first, the operator changed the device with same lot number (lot: 0004076953), but no success.Then they changed the device again with a different lot number (lot: 0004045851) and no recurrence of the incident.

• Brand Name: PACKAGE ASSEMBLY,INFANT FLOW,LP
• Common Device Name: GENERATOR AND CIRCUITS
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9593438
• Report Number: 8030673-2020-00068
• Device Sequence Number: 3012493
• Product Code: BZD
• UDI-Device Identifier: 50846446004616
• UDI-Public: (01)50846446004616(10)0004076953
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K031745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

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: PACKAGE ASSEMBLY,INFANT FLOW,LP
• Device Catalogue Number: 7772020LP
• Device Lot Number: 0004076953
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention