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

Model Number 3100 A

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

The field service representative performed and completed several calibrations to this unit such as airway pressure monitor transducer, pneumatic check and/or adjustment, alarm function test, driver displacement indicator adjustment, driver controller adjustment, pulse width modulator (pwm) adjustment, patient circuit calibration and a performance test.There was no problem detected as the unit operates within specification.The field service representative recommends that the device must undergo for 12k/7yr preventive maintenance.Any additional information received from the customer will be included in a follow-up report.

Event Description

The customer reported all the settings on 3100a ventilator were drifting including the frequency while ventilating on a patient.The patient was transferred to another ventilator.At this time, patient harm is unknown.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• 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: mindy faber ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8727570116
• MDR Report Key: 9701923
• MDR Text Key: 183135267
• Report Number: 2021710-2020-11386
• Device Sequence Number: 1
• Product Code: LSZ
• 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
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• 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: 01/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2009
• 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
• Patient Outcome(s): Required Intervention