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

Model Number 3100A

Device Problem Failure to Cycle (1142)

Patient Problem No Information (3190)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

The field service engineer (fse) went on-site to evaluate the suspect device.The fse cycled the device on and was able to duplicate the reported device behavior.The fse determined the likely cause of this failure was associated with user error and the equipment device was out of calibration.

Event Description

The customer reported this ventilator device failed to cycle intermittently, while in patient use.The customer stated that no patient information regarding patient impact had been reported.

• 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: 9578226
• MDR Text Key: 174662887
• Report Number: 2021710-2020-11251
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)20060925
• 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: 12/17/2019

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
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2006
• 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): Other