MAUDE Adverse Event Report: VYAIRE MEDICAL BELLAVISTA 1000E 17,3" BASIC VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	BELLAVISTA 1000E 17,3" BASIC VENTILATOR
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire that the bellavista stopped working properly in high flow mode and the patient was close to saturation.After switching off the device briefly in standby mode and switching it back on, the flow worked as normal, and the patient's spo2 value stabilized.No patient harm was reported.
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).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.
Additional Manufacturer Narrative
Results of investigation: no failure detected.Unit functioned as designed.External o2 supply got interrupted which trigger the o2 supply failure which in turn reduce the o2 level.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: BELLAVISTA 1000E 17,3" BASIC VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL
• Manufacturer (Section G): TECHNOCOM SYSTEMS SDN BHD; plo 1, jalan firma 1, kawasan; perindustrian tebrau 1; johor bahru ; MY
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 8477865998
• MDR Report Key: 19135953
• Report Number: 2021710-2024-19031
• Device Sequence Number: 11932922
• Product Code: CBK
• UDI-Device Identifier: 10190752197701
• UDI-Public: (01)10190752197701
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K163127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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: BELLAVISTA 1000E 17,3" BASIC VENTILATOR
• Device Catalogue Number: 301.100.100
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 08/26/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown