MAUDE Adverse Event Report: VYAIRE MEDICAL AVEA VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number AVEA

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Vyaire complaint #: (b)(4).Any additional information provided by the customer will be submitted in a follow-up report.At this time, vyaire has not received the suspect device/component for evaluation.

Event Description

The customer reported that the user interface module (uim) of avea ventilator flickers.The customer confirmed that there was no patient involvement associated with the reported event.

• Brand Name: AVEA VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs, ca
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, il ; 3273284
• MDR Report Key: 10353694
• MDR Text Key: 201351883
• Report Number: 2021710-2020-12257
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10846446000955
• UDI-Public: (01)10846446000955(11)20070123
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103211
• 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: 07/01/2020

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: AVEA
• Device Catalogue Number: AVEA STD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/31/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2007
• 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