MAUDE Adverse Event Report: VYAIRE MEDICAL 3100A VENTILATOR; VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problem Failure to Cycle (1142)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

The customer reported the suspect ventilator device is available for analysis and an onsite service by a vyaire field service representative has been scheduled.Vyaire will include the field service report and the device/component evaluation in a follow-up report once the final evaluation is completed.

Event Description

The customer reporting the oscillator device"failed while in patient use".The customer stated the device alarm and the display readings were incorrect.The customer stated the patient was placed on an alternate device and no patient compromise was associated with this event.

Manufacturer Narrative

Field service rep evaluation: the field service engineer (fse) went on-site to evaluate the suspect device.The fse cycled the device on and was able to duplicate the reported device behavior.The fse performed a preventative maintenance on the device and replaced additional suspects assemblies.However, the issue was not resolved and due to the age of the device, the whole device was sent to our manufacture site for further evaluation.Result of investigation: the vyaire failure analysis group received the suspect device for an investigation.The fa group performed a visual inspection and found no anomalies.The investigation employed relevant empirical testing of the actual device suspected in the reported adverse event in order to establish their functional and other properties and to identify possible causes for the adverse event.Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.However, no component failure was found therefore, no root cause can be established.

• Brand Name: 3100A VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8243828
• MDR Text Key: 132922572
• Report Number: 2021710-2019-09785
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• 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-RFB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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