MAUDE Adverse Event Report: VYAIRE MEDICAL, INC P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number MICROBLENDER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/18/2017

Event Type  Injury  

Manufacturer Narrative

At this time, vyaire has not received the suspect device from the customer for evaluation.Several attempts have been made to contact the customer for additional information and to evaluate the suspect device for the reported issue.At this time, the customer has not responded to any contact attempts and vyaire medical is unable to confirm the customer's reported device issue.

Event Description

The customer reported while using the low flow air/oxygen blender; the device was only administering twenty one percent and not an one hundred percent supply of oxygen.The customer reported an infant patient required administration of surfactant which requires the patient to be intubated.The customer reported that the low flow air/oxygen blender in the neonatal intensive care unit was being used for the intubation process in order to provide adequate supply of oxygen.The customer reported after successful intubation, the staff administered breaths however the infant's saturations did not rise.The customer reported attempts to change the mask, check connections and adjust the settings were performed, however did not resolved the issue.The customer reported with no clinical changes the infant was extubated, then re-intubated.The customer reported the heart rate dropped and chest compressions were administered.The customer reported the respiratory therapist arrived with a ventilator and the patient's oxygen saturation immediately rose.The customer suspects that the most likely cause of the reported event is the low flow air/oxygen blender.

• Brand Name: P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• 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: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7158475
• MDR Text Key: 96185832
• Report Number: 2021710-2018-07240
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MICROBLENDER
• Device Catalogue Number: 03920A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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