MAUDE Adverse Event Report: VYAIRE MEDICAL INC LTV VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Catalog Number	18984-001-99
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vyaire medical investigation file # (b)(4).81 other ¿ currently, the suspect device has not been returned for evaluation.Therefore, a root cause has not been determined.No patient harm or injury.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical the ltv ventilator presented a low pressure alarm.The patient went into cardiac arrest.Cpr was initiated and return of spontaneous circulation was achieved.The patient was switched over to another ventilator.No injury or harm to the patient.
Additional Manufacturer Narrative
The reported complaint was verified through the events log by vyaire medical's failure analysis (fa) lab, but not duplicated.Uut (unit under test) was functioning normally.The fa lab replaced the main pcba, sounder, and turbine manifold assembly as a precautionary measure.Replaced material as required, reworked to current configuration, recalibrated, and retested per specifications and standards.

• Brand Name: LTV VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 8478865998
• MDR Report Key: 19488848
• Report Number: 3013421741-2024-00161
• Device Sequence Number: 12897845
• Product Code: CBK
• UDI-Device Identifier: 10190752115644
• UDI-Public: (01)10190752115644(11)20110328
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K101643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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 Catalogue Number: 18984-001-99
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2011
• 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