MAUDE Adverse Event Report: VYAIRE MEDICAL 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); HFOV-HIGH FREQUENCY OSCILLATING VENTILATOR

Model Number 3100 A

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 08/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service engineer (fse) went on-site to evaluate the suspect device.The fse found the connection to the ti meter was making poor contact.The connector was taken apart and tightened the pin connections.He ran the vent and it was operating to correct specifications and ready for use.

Event Description

It was reported to vyaire that the vela ventilator experienced issues with the inspiration time.It was reported that it would only reach 26% during patient use.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: HFOV-HIGH FREQUENCY OSCILLATING VENTILATOR
• 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: 10681195
• MDR Text Key: 211450335
• Report Number: 2021710-2020-12674
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(10)20050402
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• 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: 08/15/2020

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: 3100 A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2020
• Initial Date FDA Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: No
• 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