MAUDE Adverse Event Report: VYAIRE MEDICAL, INC 3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

Vyaire medical reference number (b)(4).At this time, vyaire medical has not received the suspect device/component from the customer 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 that the blender failed while the ventilator was in use on a patient.Despite what the blender knob was set to, the blender delivered 60% fio2.The end-users tried setting the blender to 21%, 50%, and 100%.The they set it at 21, 50, and 100%.The end-users removed the ventilator from the patient and hand ventilated the patient.The customer reported that there were severe complications with the patient, but did not provide any further details.

Manufacturer Narrative

Results of investigation: the vyaire failure analysis laboratory received the suspect device and performed a failure investigation.The reported issue was duplicated in the laboratory setting.The root cause of the reported issue revealed the loose locking nut of the front stem is not making enough contact to make an actual adjustment from 60%.

Event Description

The customer reported that the blender failed while the ventilator was in use on a patient.Despite what the blender knob was set to, the blender delivered 60% fio2.The end-users tried setting the blender to 21%, 50%, and 100%.The they set it at 21, 50, and 100%.The end-users removed the ventilator from the patient and manually ventilated the patient.The customer reported that there were severe complications with the patient, but did not provide any further details.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: avery foster ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7629872
• MDR Text Key: 112038060
• Report Number: 2021710-2018-08009
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• 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-RNT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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