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

Model Number 3100A

Device Problem Calibration Problem (2890)

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

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

A vyaire field service representative (fsr) went onsite and evaluated the ventilator.Verified correct setup & calibration of blender.Reviewed setup and calibrate with staff on site.Verified operation of power supply, pressure xdcr/transducer, and ddi/device driver's interface calibration.Ran patient circuit calibration and performance check.All tests passed required criteria.Unit meets factory specifications.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported to vyaire medical that the 3100a unit connected and running.However, the blender was not connected correctly and our patient got 100% oxygen regardless of the blender being set on 21%.This ended up causing very high pa02(partial oxygen pressure) results and took a lot of troubleshooting to correct.The reporter confirmed that there is a patient involvement associated on this event.However, no harm noted.

• 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: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 11691020
• MDR Text Key: 246212817
• Report Number: 2021710-2021-13737
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)20201223
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2021

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
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2020
• 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