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

Model Number PACKAGE ASSEMBLY,INFANT FLOW,LP

Device Problem Pressure Problem (3012)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/11/2019

Event Type  Injury  

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 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
• Type of Device: GENERATOR AND CIRCUITS
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion85; parque undustrial mexicali iii; mexicali, 21397 ; MX 21397
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 9593438
• MDR Text Key: 188823347
• Report Number: 8030673-2020-00068
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 50846446004616
• UDI-Public: (01)50846446004616(10)0004076953
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PACKAGE ASSEMBLY,INFANT FLOW,LP
• Device Catalogue Number: 7772020LP
• Device Lot Number: 0004076953
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention