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

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

Device Problem Failure to Recalibrate (1517)

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

Event Date 04/02/2024

Event Type  malfunction  

Event Description

It was reported to vyaire that the 3100a vent¿s frequency panel meter only reached 14.9.No patient involvement.

Manufacturer Narrative

Vyaire medical file identification: (b)(4).H3:81 other-the suspect device was not returned for evaluation, therefore a definitive root cause could not be determined.The customer requested an onsite repair.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; 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 ; 8477865998
• MDR Report Key: 19202861
• MDR Text Key: 341298815
• Report Number: 2021710-2024-19064
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)20141106
• 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
• Report Date: 04/29/2024

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: 3100A VENT,115V,60HZ,DOM
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1