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 Problems Abnormal Blood Gases (1034); No Consequences Or Impact To Patient (2199)

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

Vyaire medical complaint number (b)(4).At this time, vyaire medical has not received the suspect device from the customer for evaluation.The customer returned the 3100a ventilator to a rental facility.The rental facility evaluated the unit and reported finding the adjust knob green cap missing and the blender knob being loose.The rental facility tightened the blender knob and performed the blender checkout and the unit meets manufacturer's specifications.After repairs, the unit passed the rental facility's safety performance inspection (spi).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 calibration test was ran on the unit and the unit was placed on a patient.When the first arterial blood gasses (abg) were drawn, the partial pressure of oxygen (pao2) was over 100 mmhg.The end-users placed an internal analyzer in-line and found that the measured fio2 was fluctuating between 30% and 100%.The end-user was not able to stabilize the fio2 on the ventilator and the patient was switched to another ventilator.There was no patient injury/harm associated with this issue.The customer reported that the blender knob was stripped and just pulled straight off the blender.

• 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: 6736667
• MDR Text Key: 80816969
• Report Number: 2021710-2017-06344
• 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
• Report Date: 07/24/2017

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-RNT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2017
• Initial Date FDA Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/1995
• 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