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

Model Number 3100A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Acidosis (2482)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

(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 it was almost impossible to ventilate the patient even though maximum adjustments were chosen.The patient's co2 value increased.The end-users decreased the piston movement, the amplitude, and the frequency, and set the power to 10.The patient's situation did not improve.The patient was placed on another ventilator and the patient's condition improved.The patient's co2 value dropped and the replacement ventilator could be set to more regular values with good amplitude.There was no permanent injury to the patient.

Manufacturer Narrative

The vyaire medical factory service center received the suspect device, a 3100a ventilator, for evaluation.An evaluation of the device verified the reported issue and found that the driver and pr3 regulator were defective.The factory service center replaced the driver the pr3 regulator and performed a complete calibration and checkout.The device meets 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: 7142874
• MDR Text Key: 95639440
• Report Number: 2021710-2017-07182
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3100A
• Device Catalogue Number: 23689-301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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