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	No Tactile Prompts/Feedback (4024)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
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 : requested troubleshooting.
Event or Problem Description
It was reported to vyaire medical that the bellavista1000e 17,3" basic ventilator only wanted to perform a shortened test when being prepared for invasive ventilation.It was not possible to select anything else.This condition will not allow the end user to have changes on settings and may compromise the patient health.No patient involvement was reported.
Additional Manufacturer Narrative
Results of investigation: intermittently proximal flow sensor calibration was skipped.The logs shared by the customer show that the circuit test is showing as "passed" prior to the proximal flow sensor calibration (phase 0) of circuit test type e.No abort reason of phase 2 is visible on logs.The failure is visible after 30 min from start up.The press blower sensor reading is 48 adc.The installed version is sw version 6.0.2100.0.The issue no longer persists after replacing the inspiration block due to press blower sensor drift.

• Brand Name: BELLAVISTA 1000E 17,3" BASIC VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd; mettawa IL 60045
• 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 ; 2402760001
• MDR Report Key: 19372402
• Report Number: 3013421741-2024-00119
• Device Sequence Number: 7678200
• Product Code: CBK
• UDI-Device Identifier: 10190752197701
• UDI-Public: (01)10190752197701(11)201901005
• 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): 05/22/2024

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: 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: 04/25/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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