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

Model Number	LTV 1200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The equipment was received in vyaire facility for evaluation.The event trace was downloaded and the ventilator is placed on extended tests/run-in.No root cause has been determined at this time, since the investigation is still ongoing.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 while using the lap top ventilator 1200 on a patient that is in mri (magnetic resonance imaging) machine, the patient desaturated and noticed that the patient had no chest rise and became pulseless.Code was initiated and rosc (return of spontaneous circulation) was achieved after one round of epinephrine and compressions.The patient was manually ventilated and returned to the icu (intensive care unit).
Additional Manufacturer Narrative
Result of investigation: equipment was received at vyaire medical facility.According to the investigation, the device was placed on extended tests/run-in.The device passed the documentation review.The event trace was downloaded and sent to vyaire failure analysis laboratory for further evaluation.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; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11283413
• Report Number: 2021710-2021-13242
• Device Sequence Number: 3721327
• Product Code: CBK
• UDI-Device Identifier: 00845873002696
• UDI-Public: (01)00845873002696(11)20190503
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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: 19260-001-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/02/2021
• 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