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

Model Number 3100A

Device Problem Failure to Cycle (1142)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

Field service rep 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 found that no oxygen was making it to the breathing gas connector on rear of ventilator.The fse determined that the blender assembly, which is not a component of the device was working intermittently.The fse performed 2 hour preventative maintenance (without blender connected), replaced the cooling and breathing gas filters.Additionally, cleaned the inlet filter on the base of the ventilator and replaced the 9v battery.The customer was informed that the blender was working intermittently and this may have caused the alarms they experienced during the incident.However, no assembly failure within the device was found 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 this oscillator ventilator device failing, while in patient use.The customer reported a "low o2 and shut down " alarm during this event.The customer stated that the patient was placed on an alternate device and no patient compromise was reported.

• 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: 8258442
• MDR Text Key: 133460323
• Report Number: 2021710-2019-09789
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/27/2018

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: 12/27/2018
• Initial Date FDA Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/1999
• 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): Required Intervention