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

Model Number 3100 B

Device Problem Pressure Problem (3012)

Patient Problems Bradycardia (1751); Pneumothorax (2012); Low Oxygen Saturation (2477)

Event Date 04/21/2019

Event Type  Injury  

Manufacturer Narrative

At this time, vyaire medical has not received the suspect device.Once received and evaluated, a follow-up medwatch report will be submitted.

Event Description

It was reported to vyaire medical that the mean airway pressure was fluctuating and caused a pneumothorax on a patient.The patient's heart rate and oxygen saturation levels decreased.The patient was removed from the device and placed on a backup device.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• 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: 8622157
• MDR Text Key: 145475856
• Report Number: 2021710-2019-10264
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100 B
• Device Catalogue Number: 770880
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/06/2008
• 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): Hospitalization; Required Intervention
• Patient Age: 1 YR
• Patient Weight: 7