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

Model Number	LTV1200
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.However,the customer reported that they did troubleshooting and the vent passes without issues.However, while running the machine, the fan is working and it's still alarming and displaying the hw fault error message.The technical support advised that the fan needs to be replaced.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 is reported to vyaire medical that the ltv 1200 experienced being pulled towards the mri while a patient is being transported.The ventilation continued working but displayed hw fault error message.The customer confirmed there was no patient harm associated with the reported issue.

• Brand Name: LTV 1200 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12463523
• Report Number: 2021710-2021-14534
• Device Sequence Number: 14675612
• Product Code: CBK
• UDI-Device Identifier: 00845873002696
• UDI-Public: (01)00845873002696(11)20200716
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2021

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: LTV1200
• Device Catalogue Number: 18888-201
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1