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

Model Number 3100A

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2017

Event Type  Injury  

Manufacturer Narrative

Vyaire medical complaint number (b)(4).At this time, vyaire medical has not received the suspect device/component from the customer for evaluation.In the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.

Event Description

The customer reported that the ventilator was not running at some point, while in use on a patient.The unit stayed pressurized.The unit was swapped out and there was no patient compromise.The customer put a test patient circuit on the unit and let the unit run for 8 hours without any issues.

Manufacturer Narrative

A vyaire medical field service representative (fsr) evaluated the device onsite.The fsr found that the pr3 pressure regulator was set too high and the ventilator was hitting the 47 cmh2o limit.The fsr also found that the pr3 was drifting slighty and replaced it.The fsr found that the frequency panel meter was out of specification.The fsr replaced the panel meter and calibrated the pressure transducer, pneumatics functions, driver controller, and driver displacement indicator.The device passed the alarms test, performance check, and patient circuit calibration.The fsr completed the operational verification procedure (ovp).The device meets manufacturer specifications.

Manufacturer Narrative

Results of investigation: the vyaire medical failure analysis laboratory received the suspect components, a 3100a panel meter and pr3 regulator.An evaluation of the components did not duplicate the reported issue.The panel meter and pr3 regulator meet manufacturer's specifications.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6860193
• MDR Text Key: 85900025
• Report Number: 2021710-2017-06619
• 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,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2005
• 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
• Patient Outcome(s): Required Intervention