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

Model Number	LTV 1200
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The equipment was received in vyaire facility for evaluation.It was seen that the fan assembly is not spinning.The power board and alarm sounder is creating the non-conformance.Service technician replaced the fan assembly, power board and alarm sounder.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported to vyaire medical that the lap top ventilator 1200 alarmed hardware fault and the ventilation stopped.The issue occurred during patient-use and the device was replaced with another ventilator.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Results of investigation: vyaire medical was able to duplicate the original complaint in the failure analysis lab.The fan assembly was found to be non-functional due to damaged fan motor circuitry.This uut (unit under test) is used in proximity of active mri(magnetic resonance imaging) machines.

• Brand Name: LTV 1200 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11283333
• Report Number: 2021710-2021-13314
• Device Sequence Number: 19763143
• Product Code: CBK
• UDI-Device Identifier: 00845873002696
• UDI-Public: (01)00845873002696(11)20131014
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

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?: Yes
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention