MAUDE Adverse Event Report: VYAIRE MEDICAL MODEL LTV 1100 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	LTV 1100
Medical Device Problem Codes	Mechanical Problem (1384); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results of investigation: vyaire medical was able to verify the customer's reported issue during testing and evaluation.The ventilator was tested with a known good ac adapter and a known good patient circuit connected.The ventilator was powered on, and a "disc/sense" alarm was active.Bench testing revealed there was no flow due to the turbine seizing and not spinning.
Event or Problem Description
It was reported to vyaire medical that the ventilator failed to achieve the correct tidal volume.There was no patient involvement associated with this reported event.
Additional Manufacturer Narrative
Vyaire complaint #: (b)(4).Device evaluation: d10, g4, g7, h2, h3, h6, h10 results of investigation: the vyaire failure analysis laboratory received the suspect component and performed a failure investigation.The reported issue was duplicated and was isolated to the unit having a seized impeller due to metal shavings lodged between the impeller and the turbine housing.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: MODEL LTV 1100 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8822714
• Report Number: 2031702-2019-03284
• Device Sequence Number: 16945327
• Product Code: CBK
• UDI-Device Identifier: 00845873003778
• UDI-Public: (01)00845873003778(11)20130604
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/24/2019

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: LTV 1100
• Device Catalogue Number: 21102-001-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1