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

Model Number 3100A

Device Problem Decrease in Pressure (1490)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2019

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 reported an intermittent drop in the delta pressure (amplitude) by 10 cmh20, while in patient use.The patient was removed and placed on an alternate oscillator ventilation device.However, the customer stated no patient impact to the patient.

Manufacturer Narrative

Field service evaluation: the field service engineer (fse) went on-site to evaluate the suspect device.The fse cycled the device on and performed the manufacture testing.Likewise, user testing was also performed based on the customer feedback.However, the reported event was not duplicated nor an assembly failure identified.Therefore, no component root cause investigation will be performed.The operational verification procedure was performed and passed.Having met manufacture specifications the device was returned for use.

• 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: 8410016
• MDR Text Key: 138455497
• Report Number: 2021710-2019-09980
• 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: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2006
• 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