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

Model Number 3100 B

Device Problem Temperature Problem (3022)

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

Event Date 08/02/2022

Event Type  malfunction  

Event Description

It was reported to vyaire medical device overheated and stopped oscillating during use on a patient on the 3100 b ventilator.At this time, there is no information regarding patient harm associated with the reported event.

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 becomes available.

Manufacturer Narrative

"results of investigation: vyaire field service representative went onsite to evaluate the device.Technician troubleshot and tested unit.Left oscillator running for one hour with settings that were on the unit at arrival with no problem.Tested oscillator for another hour with the performance check settings and unit worked within manufacturer specifications.Unit is ready for use.".Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. 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 dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15307478
• MDR Text Key: 305414595
• Report Number: 2021710-2022-16542
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003543
• UDI-Public: (01)10846446003543(11)20100205
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

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: 3100 B
• Device Catalogue Number: 770155
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 07/28/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2010
• 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