MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. 3100A; VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problem Failure to Recalibrate (1517)

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

Event Date 04/10/2019

Event Type  malfunction  

Event Description

Oscillator switched out due to mean airway pressure (map) fluctuating from higher to lower than desired map.Multiple failed attempts to recalibrate the oscillator that the patient was originally on, so oscillator was switched out to a new one.The oscillator was pulled from the patient bedside and replaced with another vent.The oscillator was tagged and biomed was called to check it out.Biomed reviewed the oscillator and determined there was an issue with the piston within the unit.The parts have been ordered and will be replaced once in.The oscillator will be fixed and ensured it's operational before placed back in service.

• Brand Name: 3100A
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 26125 north riverwoods blvd; mettawa IL 60045
• MDR Report Key: 9990307
• MDR Text Key: 188659108
• Report Number: 9990307
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3100A
• Device Catalogue Number: 768901
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 365 DA