MAUDE Adverse Event Report: VYAIRE MEDICAL INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION; VENTILATOR, NON-CONTINUOUS

Model Number SIPAP

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Vyaire medical was able to confirm the customer's reported issue during testing and evaluation.This reported issue was due to a defective flow meter.Vyaire medical replaced the flow meter to address the customer's reported issue and performed the 2 year preventative maintenance on the unit.

Event Description

It was reported to vyaire medical that the flow meter was erratic.There was no report of any patient involvement associated with this reported event.

Manufacturer Narrative

Results of investigation: vyaire medical conducted failure analysis testing on the defective component.Visual inspection of the assembly revealed no signs of any physical damages.The flow meter was installed into a test fixture and powered on to service mode.The test fixture was checked for errors on the screen, no errors were presented.The user verification test was performed and the leak test.The unit passed by confirming the setting.Pressure calibrations were also performed, and all calibrations were passed; cleared all faults by pressing error button, no anomalies were found.

• Brand Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
• Type of Device: VENTILATOR, NON-CONTINUOUS
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8191960
• MDR Text Key: 131307268
• Report Number: 2021710-2018-09714
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

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
• Device Operator: Health Professional
• Device Model Number: SIPAP
• Device Catalogue Number: 27416-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 04/12/2019
• Supplement Dates FDA Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1