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

Model Number 3100A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

Field service rep evaluation: the field service engineer (fse) went on-site to evaluate the suspect device.The field service engineer (fse) cycled the device and confirmed the reported device behavior.The fse determined the driver power module (dpm), as the cause of the reported event.The fse replaced the dpm and performed the operational verification of the device, which passed.The device was returned to the customer for use, having met manufacture specifications.

Event Description

The customer reported the frequency setting was not being displayed during patient use on this ventilator device.The customer stated no patient harm or injury was reported or known with this event.

Manufacturer Narrative

Result of investigation: the vyaire failure analysis (fa) group received the suspect driver for an evaluation.The fa group performed power cycle startup, physical and visual inspection of the internal driver components, which found no anomalies.The fa was able to duplicate the reported event by the customer.At this time, the component root cause is associated with a material issue related to a voltage issue within a subcomponent of the driver.This issue will be internally investigated within vyaire.

• 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: avery foster ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7623359
• MDR Text Key: 111818141
• Report Number: 2021710-2018-08005
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 03/09/2019
• Supplement Dates FDA Received: 04/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2008
• 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