MAUDE Adverse Event Report: VYAIRE MEDICAL LTV 1000 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	LTV 1000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 was received.
Event or Problem Description
The customer reported that the dial knob on the lap top ventilator 1000 unit was not able to change the fio2 (fraction of inspired oxygen) higher than 50% and the knob was stuck on parameters after changing the value 1 digit at a time.The issue occurred during patient use while in ct (computed tomography) evaluation which leads to desaturation, increased the peep (positive end-expiratory pressure) to +10 and fio2 and kept fio2 at 50%.The ventilator was taken out of service when the patient returned to the icu (intensive care unit).The customer confirmed that the patient recovered and had no lasting effects.

• Brand Name: LTV 1000 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 10588624
• Report Number: 2031702-2020-03690
• Device Sequence Number: 19137321
• Product Code: CBK
• UDI-Device Identifier: 00845873000203
• UDI-Public: (01)00845873000203(11)20001121
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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 1000
• Device Catalogue Number: 10130
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/25/2020
• 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