MAUDE Adverse Event Report: VYAIRE MEDICAL BLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number	03800A
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Retinal Injury (2048)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A vyaire representative went on-site to investigate the reported event.The vyaire representative was able to confirm the suspect device remains quarantine while the user facility conducts internal testing.The customer reported no evaluation could be performed at this time.A review of vyaire's service record show the device has not been sent to vyaire for routine overhaul intervals as recommended.The vyaire representative confirmed the suspect device was being maintained by the user facility's biomed.At this time, it is unknown whether or not initial performance checks were performed prior to use, use of external analyzers were used to verify performance, and if suspect device was serviced or calibrated by a vyaire trained technician.A contributing factor to the reported event may be due to blender maintenance service history.Any additional information received from the customer will be included in a follow-up report.
Event or Problem Description
The customer reported a suspected serious injury involving a bird 3800a microblender that was detected at the user facility.On (b)(6) 2019 it was discovered that the dial was set at twenty-one percent (21%) oxygen (o2).However, was found delivering ninety-six percent (96%) o2 when analyzed.The issue occurred on a premature neonate.On (b)(6) 2019, the neonate underwent an eye examination which showed bilateral retinopathy of prematurity.The customer reported the involved machine was immediately taken out of service on (b)(6) 2019 and was confirmed to be administering the incorrect oxygen blend.

• Brand Name: BLENDER
• Common Device Name: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8691250
• Report Number: 2021710-2019-10365
• Device Sequence Number: 1935922
• Product Code: BZR
• UDI-Device Identifier: 10846446002348
• UDI-Public: (01)10846446002348
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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
• Operator of Device: Health Professional
• Device Model Number: 03800A
• Device Catalogue Number: 03800A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other