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

Model Number 3100A VENT,115V,60HZ,DOM

Device Problem Incorrect Measurement (1383)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

It was reported to the vyaire medical that the 3100a is unable to reach needed amplitude.Furthermore, there was no patient associated with the reported event.

Manufacturer Narrative

Vyaire medical file identification: (b)(4).H3:81 other: the suspect device has not been return for investigation.Furthermore, no root cause has been determined yet.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 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18460845
• MDR Text Key: 332732462
• Report Number: 2021710-2024-18630
• 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: Health Professional,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100A VENT,115V,60HZ,DOM
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• 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