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

Model Number 3100A

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2022

Event Type  malfunction  

Manufacturer Narrative

"vyaire file identification: (b)(6).The device was not be returned for further evaluation; therefore a definitive root cause could not be determined and corrective or preventive action is not indicated at this time.However, the customer checked the driver assy and discovered that the resistance is approximately 3 ohm.Checked the power supply board and discovered +5v, +15v, and -15v.Performed pressure calibration and piston position and displacement display calibration on r1 and r7 but not on r4.The customer then requested troubleshooting tips and a service manual for this new series of hfov as soon as possible.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported to vyaire medical that the 3100a ventilator is not producing oscillation and that pressure is building up in the circuit.The circuit was calibrated, but when starting the oscillator, it does not start, and the "oscillator stopped" visual and audio alarms sound.Furthermore, there was no patient associated with the reported event.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 15915804
• MDR Text Key: 307693449
• Report Number: 2021710-2022-16998
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446005561
• UDI-Public: (01)10846446005561
• Combination Product (y/n): N
• Reporter Country Code: KU
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/05/2022

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: 3100A
• Device Catalogue Number: 3100A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/05/2022
• 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