MAUDE Adverse Event Report: VYAIRE MEDICAL LTM II; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	LTM II
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification:(b)(4).The equipment was received in vyaire facility for evaluation.No root cause has been determined at this time.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.
Event or Problem Description
The customer reported to vyaire medical that the assy, packaging ltm ii unit has malfunctioning screen.The reporter confirmed that there is no patient involvement associated on this event.

• Brand Name: LTM II
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11803172
• Report Number: 2021710-2021-13878
• Device Sequence Number: 14364195
• Product Code: CBK
• UDI-Device Identifier: 00845873000333
• UDI-Public: (01)00845873000333(11)20160308
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2021

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: LTM II
• Device Catalogue Number: 17650-001-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1