MAUDE Adverse Event Report: LOW FLOW AIR/OXYGEN MICROBLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number	LOW FLOW BLENDER
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.The suspect device will be repaired by the eu office.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.
Event or Problem Description
The customer reported to vyaire medical that the infant flow sipap ventilator unit was having fraction of inspired oxygen(fio2) inaccuracy issue.At this time, there is no information regarding patient involvement associated with the reported event.
Event or Problem Description
The customer reported fio2 (fraction of inspired oxygen) inaccuracy with the low flow blender.It was stated that the deviation is too big.There is no information regarding patient involvement with the incident.
Additional Manufacturer Narrative
Results of investigation:the unit was repaired by the eu office.The service technician was able to verify and fix the fault by calibration.

• Brand Name: LOW FLOW AIR/OXYGEN MICROBLENDER
• Common Device Name: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• MDR Report Key: 12174938
• Report Number: 2021710-2021-14176
• Device Sequence Number: 16377658
• Product Code: BZR
• UDI-Device Identifier: 10846446004847
• UDI-Public: (01)10846446004847(11)20070124
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021
• 2 Devices were Involved in the Event: 1 2

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: LOW FLOW BLENDER
• Device Catalogue Number: 11329
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1