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

Model Number 3100A HFOV

Device Problem Failure to Cycle (1142)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

Field service device evaluation: the field service engineer (fse) went on-site to evaluate the suspect device.The fse cycled the device on and was not able to duplicate the reported device behavior.The fse did not find any assembly failure.However, it is believed that improper use was traced to the user, which likely attributed to improper device operation.At this time, a definitive root cause could not be determined 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.

Event Description

The customer reported the device failed to cycle, while in patient use.The customer reported removing the device and placing the patient on an alternate device.No patient harm or injury was reported with this event.

• Brand Name: 3100A 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: 8930486
• MDR Text Key: 155505400
• Report Number: 2021710-2019-10711
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)20080528
• 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: 08/02/2019

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 HFOV
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2008
• 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): Required Intervention