MAUDE Adverse Event Report: VYAIRE MEDICAL LTV 1200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	LTV 1200
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to vyaire medical problems with lap top ventilator 1200.The respiratory therapist noted a high pressure reading, but inaccurate.The vent is also due for pm.Furthermore, the customer confirmed that alternative ventilation was provided to the patient.Respiratory therapist was able to switch the ventilator and there was no patient harm reported associated with the event.
Additional Manufacturer Narrative
The suspect device was returned and evaluation is anticipated but not yet begun.Once a final investigation is complete, a follow-up report will be submitted.
Additional Manufacturer Narrative
Results of investigation: vyaire medical received the suspect device for evalution.Event trace download reveals several high-pressure alarm condition occurred but was unable to duplicate during bench testing at service.All testing was performed with a good known test ac adapter, patient circuit, and test lung.Vent passed 48 hours extended tests at customer settings with no unusual alarms or conditions.Vent passed ts final checkout test (service manual 33132-001 version b )which includes many alarm and ventilation functions.Process vent thru service and perform complete checkout to meet all factory specification and standards.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: LTV 1200 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 14432075
• Report Number: 2021710-2022-16049
• Device Sequence Number: 15069262
• Product Code: CBK
• UDI-Device Identifier: 10190752115637
• UDI-Public: (01)10190752115637(11)20180110
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K060647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 04/19/2022

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: LTV 1200
• Device Catalogue Number: 18888-201-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2018
• 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