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

Model Number 3100A

Device Problem Failure to Cycle (1142)

Patient Problem Death (1802)

Event Date 11/04/2018

Event Type  Death  

Manufacturer Narrative

Field device evaluation - the field service engineer (fse) went on-site to evaluate the suspect device.The fse cycled the device on and used the user settings, which were used at the time of this reported event.After cycling the device for a period of time the reported device behavior "the piston drifted and the device stopped cycling" was not reproduced.The fse then performed manufacture testing, which the device passed.Additionally a two thousand hour preventative maintenance calibration was performed on this device.At this time, no assembly failure was found therefore, no component root cause can be determined.Vyaire medical does not believe this device contributed to the patient outcome.Furthermore, no allegation by the customer that this device contributed to the patient death.

Event Description

The customer reported, while in patient use the piston drifted to its maximum limit and stopped cycling on this oscillator ventilator device.The patient was removed from this device however, during the transition from this device to an alternate device the patient expired.The hospital biomed reported evaluating this suspect device however, he was unable to duplicate the reported device behavior and requested an onsite vyaire manufacture evaluation of this device.

• Brand Name: 3100A VENTILATOR
• 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: 8108370
• MDR Text Key: 128488655
• Report Number: 2021710-2018-09604
• Device Sequence Number: 1
• Product Code: LSZ
• 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: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• 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
• Date Manufacturer Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/1999
• 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): Death; Required Intervention