MAUDE Adverse Event Report: VYAIRE MEDICAL ASSY,LTV2200,W-ACCY,ENGLISH; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	ASSY,LTV2200,W-ACCY,ENGLISH
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : not returned.
Event or Problem Description
It was reported to vyaire medical that "suddenly the unit started having high fan noise while on patient which worried the user of a fault or overheating which resulted in removing the unit.The unit is new with minimum usage." swapped out device for different unit.No patient harm reported.
Additional Manufacturer Narrative
H3: root cause findings: the reported problem was not duplicated.Disposition: route ltv 2200 service repair p/n 22690-001-99 s/n (b)(6) s/v 01.08 to factory service to have fan assembly replaced and disposed of as a precautionary measure, then have assembly processed.
Event or Problem Description
Additional information received indicates that the ventilator was returned for further investigation.The reported problem was not duplicated.

• Brand Name: ASSY,LTV2200,W-ACCY,ENGLISH
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 19193452
• Report Number: 2021710-2024-19057
• Device Sequence Number: 15571827
• Product Code: CBK
• UDI-Device Identifier: 10190752139220
• UDI-Public: (01)10190752139220
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

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: ASSY,LTV2200,W-ACCY,ENGLISH
• Device Catalogue Number: 22690-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2020
• 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