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

Model Number 766897

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2019

Event Type  Injury  

Manufacturer Narrative

The customer reported the suspect bellows water trap component item (b)(4) is available for analysis and a return good authorization (rga) has been issued.At this time, vyaire medical has not received the suspect bellows water trap component 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 a low mean airway pressure setting, while in patient use on an oscillator device.The customer reported trouble shooting and found the bellows water trap (b)(4) consumable item, was leaking water from the drain component.The customer stated the patient was placed on an alternate device and no patient compromise was associated with this event.

• Brand Name: 3100 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: 8348313
• MDR Text Key: 136478139
• Report Number: 2021710-2019-09892
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 20846446003403
• UDI-Public: (01)20846446003403
• 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
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 766897
• Device Catalogue Number: 766897
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention