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

Model Number 3100 A

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Patient Involvement (2645)

Event Date 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information provided by the customer will be included in a follow up report.At this time, vyaire has not received the suspect device/component for evaluation.Investigation is ongoing.

Event Description

The customer reported that the 3100a mean airway pressure/cpap will not adjust or go above 10.At this time, there is no patient involvement associated with the event.

Manufacturer Narrative

A field service representative is able to verify the customer's reported issue.Fsr found ddi off center.They calibrate ddi and verified and passed all performance checks.The device passed all testing and met all vyaire manufacturer specifications.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8727570116
• MDR Report Key: 9656744
• MDR Text Key: 189671417
• Report Number: 2021710-2020-11300
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)20031218
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2020
• 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
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1