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

Model Number 3100A

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 03/22/2022

Event Type  Injury  

Event Description

It was reported to vyaire medical that the hfov (high frequency oscillator ventilation) of the 3100a was paused to bag and suction a picu (pediatric intensive care unit) patient.Upon going back, the unit was found to be frozen and would not resume treatment even after checking the set and fittings.However, it started when it was moved, and treatment was resumed.A short while later, after more intervention done by the nursing team, the same thing happened again.The unit was replaced with a backup device.Unknown harm.

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.

• Brand Name: 3100A VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 14138544
• MDR Text Key: 289504117
• Report Number: 2021710-2022-15917
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446005561
• UDI-Public: (01)10846446005561(11)20140611
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100A
• Device Catalogue Number: 23689-301
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/11/2014
• 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