MAUDE Adverse Event Report: VYAIRE MEDICAL BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number	SENTRY BLNDR/ANALYZR,HI FLO,DISS
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification:(b)(4).H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.
Event or Problem Description
It was reported to vyaire medical that the sentry blender's display does not work.Last maintenance was in february 2023.As of this time, there is no information of patient involvement associated with this reported event.
Additional Manufacturer Narrative
Additional information: g3, g6, h2, h6 and h11 additional information: vyaire sent a loaner blender to the customer but it was returned.The customer stated that the suspect device (original blender) was not actually defective.So, there was never a blender sent to the repair department for investigation.Therefore, the complaint has been closed.

• Brand Name: BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER
• Common Device Name: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL, INC PALM SPRINGS; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 8477865998
• MDR Report Key: 18132666
• Report Number: 2021710-2023-18397
• Device Sequence Number: 12700856
• Product Code: BZR
• UDI-Device Identifier: 10846446002201
• UDI-Public: (01)10846446002201
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K973646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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: SENTRY BLNDR/ANALYZR,HI FLO,DISS
• Device Catalogue Number: 15625
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown