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

Model Number	MICBLNDR,W/O HOSE,3 OUTLET,H/L
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.At this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determined yet.
Event or Problem Description
The customer reported that the fio2 (fraction of inspired oxygen) of the blender is out of specification.At this time, there is no information about patient involvement.
Additional Manufacturer Narrative
Device evaluation: d10, g4, g7, h2, h3, h6 and h10.Result of investigation: the vyaire failure analysis laboratory received the device.A visual inspection of blender p# 03803t s/n (b)(6) found the control knob having indications of physical damage as after removing the control knob cover i found the torque seal that is used to determine tampering with the front seat (reference eco 103120 released 08jul20) was damaged showing that the calibrating most likely shifted.As this damage would cause inaccurate readings due to the state of the front seat being shifted from its original set calibration, it was the reason we are unable to accurately test the blender to determine the true state of calibration once shipped out of factory service.Physical damage to front seat caused its original calibration to shift after being overhauled from the factory service department.

• Brand Name: MICROBLENDER
• Common Device Name: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10485774
• Report Number: 2021710-2020-12473
• Device Sequence Number: 4093301
• Product Code: BZR
• UDI-Device Identifier: 10846446002256
• UDI-Public: (01)10846446002256
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K883038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MICBLNDR,W/O HOSE,3 OUTLET,H/L
• Device Catalogue Number: 03803T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1