MAUDE Adverse Event Report: VYAIRE MEDICAL INC. LTV 2200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	LTV 2200
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was returned and evaluation is anticipated but not yet begun.Once a final investigation is complete, a follow-up report will be submitted.
Event or Problem Description
The customer reported that the peep (positive end-expiratory pressure) kept dropping out and then coming back up constantly on the ltv 2200 lap top ventilator during patient use.The device was replaced with another ventilator and there was no patient harm reported associated with the reported event.
Additional Manufacturer Narrative
Device evaluation: results of investigation: the suspect device was returned for investigation.Vyaire medical was not able to verify the customer complaint regarding peep kept dropping out and then coming back up constantly.The original complaint was not duplicated in the fa lab.The uut (unit under test) was tested and found to function within expectations.Visual inspection of the uut found no damage.The uut was installed on a test stand as received to undergo testing.The uut was powered on in operational mode and the ventilator was allowed to cycle in user configuration.The uut underwent peep calibration per ltv2 service manual chapter 8; f1 through f5, passing on all counts.It also underwent peep testing per ltv2 service manual chapter 9; b1 through b8, passing on all counts as well.Unit will move to receiving and to route the item to the service department.Fa recommendation is to replace material as required, rework to current configuration, recalibrate, and retest per specifications.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: LTV 2200 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 14107468
• Report Number: 2021710-2022-15884
• Device Sequence Number: 4776708
• Product Code: CBK
• UDI-Device Identifier: 10190752139220
• UDI-Public: (01)10190752139220(11)20200827
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K101643
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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 2200
• Device Catalogue Number: 22690-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 06/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2020
• 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