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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The equipment was received in vyaire facility for evaluation.The event trace was downloaded and being reviewed.The unit is placed on extended tests using customer's settings.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 the lap top 1000 ventilator occurred low tidal volume.The issue occurred during patient-use and the device removed from the patient.The customer confirmed that there was no patient harm associated with the reported event.

• Brand Name: LTV 1000 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13212852
• Report Number: 2021710-2021-15320
• Device Sequence Number: 1505296
• Product Code: CBK
• UDI-Device Identifier: 10190752114067
• UDI-Public: (01)10190752114067(11)20000815
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2021

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 1000
• Device Catalogue Number: 10130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2000
• 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