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

Model Number 3100 A

Device Problem Improper Flow or Infusion (2954)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

A vyaire field service representative (fsr) went onsite and evaluated the ventilator.Fsr replaced the mean pressure panel meter assembly.All work accomplished per 3100a service manual rev.H.Fsr performed patient circuit calibration and performance check, unit passes.The ventilator is operational and meets oem specifications.

Event Description

The customer reported that the map (main airway pressure) of 3100a has too much variability while connected to a patient.At this time, there is no information regarding patient harm and remedial action taken by the healthcare facility associated with the reported event.

Manufacturer Narrative

Device evaluation: b1, b2, d10, g4, g7, h1, h2, h3, h6 and h10 device evaluation: the vyaire failure analysis laboratory received the suspect component and performed a failure investigation.The issue reported by the customer could not be duplicated.The assembly was installed into a known good unit and no fluctuations were found during the operation.The system was left to cycle overnight and the readings did not change.The panel meter was sent to the manufacturing line for testing and passed with a reading of 50.0 which is what is expected.Additional information: the patient was removed from the ventilator.The customer confirmed that there was no patient harm associated with the reported event.

• 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
• MDR Report Key: 10182184
• MDR Text Key: 196116317
• Report Number: 2021710-2020-12126
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079
• Combination Product (y/n): N
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100 A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention