MAUDE Adverse Event Report: VYAIRE MEDICAL MODEL LTV 1150 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	18984-001
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that high rates occurred during use on a patient on the lap top ventilator 1150.It would jump from 14 to 20, 30 and back down.The settings are a/c (assist-control) rate 14, vt (tidal volume) 500 cc, peep (positive end-expiratory pressure) 5 and sensitivity is 1.0.The customer confirmed there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
D4:corrected model#.G4:corrected pma/510k.Sections d4 and g4 has been updated to indicate the correct model# and pma/510k.

• Brand Name: MODEL LTV 1150 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. 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 ; 2402760001
• MDR Report Key: 18132573
• Report Number: 2021710-2023-18395
• Device Sequence Number: 7581287
• Product Code: CBK
• UDI-Device Identifier: 10190752115644
• UDI-Public: (01)10190752115644
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K051767
• 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): 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: 18984-001
• Device Catalogue Number: 18984-001
• 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: 06/20/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 06/20/2024
• 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