MAUDE Adverse Event Report: VYAIRE MEDICAL LTV 1200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	LTV1200
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A third party service technician evaluated the ventilator and it was seen that the battery life was short (28 min).The service technician replaced the power board and internal battery to address the customer's reported issue.
Event or Problem Description
The customer reported that the lap top ventilator 1200 with newly installed battery alarmed reset (ln vent).At this time, there is no information regarding patient involvement associated with the reported event.
Additional Manufacturer Narrative
Result of investigation: vyaire medical was able to confirmed the reported issue.Uut (unit under test) failed lap top ventilator battery charge and duration test.There might be a chemical problem with the internal cells of the battery.If in the future, the trends start to appear with this battery, further analysis will be conducted.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: LTV 1200 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 10702009
• Report Number: 2031702-2020-03711
• Device Sequence Number: 11556944
• Product Code: CBK
• UDI-Device Identifier: 00845873002641
• UDI-Public: (01)00845873002641(11)20160819
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: LTV1200
• Device Catalogue Number: 18888-006
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1