MAUDE Adverse Event Report: VYAIRE MEDICAL 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	03/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to vyaire medical that the lap top ventilator 2200 alarmed chk (check) circuit.The peep (positive end expiratory pressure) and inspiratory pressure are not according control.The customer confirmed that there is no patient involvement associated with this reported event.
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).The device was received and checked for the related failure.The lap top ventilator 2200 pass the leak test but chk circuit alarm was present.The peep (positive end-expiratory pressure) and the inspiratory pressure are not according to control.As a resolution, the analog board, accumulator, ppin ppout solenoid assembly was replaced but the failure remains the same.The solenoid manifold was replaced and the failure was solved.Based on the analysis the failure is on solenoid manifold.In addition to the reported failure unit fail red led screen.Based on failed red led screen check also the failure on main board.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; 510 technology dr; irvine IL 92618
• 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: 12860559
• Report Number: 2021710-2021-15034
• Device Sequence Number: 17201689
• Product Code: CBK
• UDI-Device Identifier: 10190752139220
• UDI-Public: (01)10190752139220(11)20200712
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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 2200
• Device Catalogue Number: 22690-001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2020
• 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
• Patient Sex: Unknown