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

Model Number 3100 B

Device Problem Increase in Pressure (1491)

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

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).H10: vyaire field service went onsite replace3 ohms driver.Cannot zero mean pressure order alarm pcb (printed circuit board).

Event Description

It was reported to vyaire medical that the 3100b when device is powered on, the map incrementally increased to max (~60cmh2o) without any intervention.The customer confirmed that there is no patient involvement associated with this reported event.

Manufacturer Narrative

Updated information:g3, g6, h2 and h10 additional information:as a resolution, replace pressure transducer pwb assembly.All work accomplished per 3100b service manual.Performed patient circuit calibration and performance check, unit passes.Vent is operational and meets oem (original equipment manufacture) specifications.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. 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 ; 8477865998
• MDR Report Key: 18622970
• MDR Text Key: 335081621
• Report Number: 2021710-2024-18720
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003543
• UDI-Public: (01)10846446003543
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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