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

Model Number 27416-001

Device Problem No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

Vyaire complaint number: (b)(4).Vyaire medical's service team was able to duplicate the customer's reported issue.The investigation revealed that the smart driver cable was not connected all the way causing a disconnect with the lcd.Once the connector was plugged in, the screen was working within specifications.No further investigation was needed.

Event Description

Vyaire medical received a customer report of the lcd not displaying.It is completely blank.Patient involvement is unknown at this time.

• Brand Name: INFANT FLOW SIPAP
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 11003889
• MDR Text Key: 221549328
• Report Number: 2021710-2020-13026
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 10846446063486
• UDI-Public: (01)10846446063486(11)20160101
• 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
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27416-001
• Device Catalogue Number: 27416-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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