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

Model Number	LTV 2200
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
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 the pressure on this unit kept rising, then would dump and back and forth during use on a patient on the lap top ventilator 2200.The customer reported the unit was swapped out.The customer reported there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Results of investigation: vyaire medical received the device for evaluation.Technician visually inspected on unit under test) assembly, there was a visible defect, damage (scratched) on the back cover.The device was powered on ventilator maintenance allowing the device to warm up at nominal settings for one hour in servo mode before performance checkout test.With costumer settings in pressure mode and after 45 minutes the device had no issues with pressure rising or pressure delivery high.Disassembled unit by removing all covers to thoroughly inspected internal printed circuit board's, cables, tubing's, and connectors.Checked high- and low-pressure sense lines which were correctly attached and securely seated at both the device and wye ends.Verified the event trace showed 385: high pres 0.Performed: general check out test, the device passed.The reported complaint was confirmed on the event trace but not duplicated.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: 14281037
• Report Number: 2021710-2022-15958
• Device Sequence Number: 4859933
• Product Code: CBK
• UDI-Device Identifier: 10190752139220
• UDI-Public: (01)10190752139220(11)20200814
• 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): 04/05/2022

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: 04/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2020
• 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