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

Model Number	03800A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	04/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, vyaire has not received the suspect device for evaluation.
Event or Problem Description
The customer reported while setting up an infant on the high frequency oscillatory ventilator (hfov), the therapist noted that patient was desalting while on one-hundred percent (100%) oxygen.After troubleshooting and adjustments, the therapist traced the o2 hose and determined that the o2 blender hose was mis-connected on the hfov.The blender did not give notice of the mis-connection by alarming.The customer reported the blender was replaced and o2 saturation readings rose on infant.Infant able to maintain o2 sat of 88 with fio2 set at 23%-28%.Blender removed and sent to biomedical (bme) for inspection.Bme inspection of blender noted that the alarm "whistle" cap was defectively not allowing blender to alarm when just one gas was connected.Bme replaced alarm cap and blender was able to alarm on air or o2 hose disconnect.

• 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: 8713829
• Report Number: 2021710-2019-10405
• Device Sequence Number: 2663560
• 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: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

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): Initial
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/19/2019
• 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: Required Intervention