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

(b)(4).At this time, vyaire medical has not received the suspect device 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 despite which setting the blender knob was set to, the delivered fio2 was only 60%, while the device was in use on a patient.The customer attached another blender to the ventilator and the blender worked correctly.The patient was on extracorporeal membrane oxygenation and the customer did not provide any further information regarding the patient's condition in relation to the reported issue.

Manufacturer Narrative

Results of investigation: vyaire medical was not able to verify the customer's reported issue during testing and evaluation.The system was supplied with air and oxygen, and the unit pressurized as intended passing the circuit leak test.The unit was cycled for 1 hour with no performance issues, however, the blender was tested at a setting of 60%, and the measured fio2 reading was 55.6%.At all other settings, the fio2 was within specification.The reported issue of the blender staying at 60% regardless of the knob setting was not duplicated and the report of the loose knob was not duplicated.The reading of the fio2 reading at a setting of 60% was due to the front stem calibrating being off.Vyaire adjusted the front stem to correct the reported issue.

• 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: 7627820
• MDR Text Key: 111973007
• Report Number: 2021710-2018-08008
• 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: 06/21/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 07/03/2018
• Supplement Dates FDA Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/1999
• 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